MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,30+4L NK,14X09X130; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 56-3514

Device Problem Fracture (1260)

Patient Problems Pain (1994); Distress (2329); Ambulation Difficulties (2544); No Code Available (3191); Limb Fracture (4518); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The patient was revised to address pain.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6 patient code: no code available (3191) used to capture the device revision or replacement.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.E3 initial reporter occupation: lawyer.

Event Description

Litigation records alleges injury, walking difficulty, mental and physical anguish, several emotional distress and depression relating to trauma of the injuries.Doi: (b)(6) 2005.Dor: (b)(6) 2018.Right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a device history record (mre) review, was not possible because the required lot code was not provided.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, b7, h6.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records received.After review of medical records patient was revised due to failed right total hip arthroplasty.Operative notes indicate upon incision and then visualized the broken neck and head.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records were reviewed and indicated that on (b)(6) 2005 right hip arthroplasty.On (b)(6) 2016, the patient had a left hip arthroplasty to address left hip osteoarthritis.Depuy components were implanted during this procedure, including a corail stem, ceramic head, pinnacle shell, and poly liner (surgery page 65 of 81)(part/lot pages 524,525 of 656).On (b)(6) 2018, the patient had a revision of right total hip arthroplasty to address failed right total hip.During the procedure, the surgeon observed a ¿broken¿ fractured femoral neck.The liner had some signs of oxidation.The liner, femoral head, and femoral stem were revised.The surgeon reported that there was a greater trochanter fracture that occurred during the preparation of the new stem and a cable and synthes trochanteric fracture plate and 2 cables were used to stabilize the fracture.Depuy reclaim stem, reclaim proximal body, ceramic head, and poly liner were implanted during this procedure (surgery page 63 of 81) (part/lot page 129 of 656 for implants implanted on (b)(6) 2018) ((b)(4) for revision, will need a new pc for bone fracture/plate and cabling as well as informing synthes as there are later allegations on (b)(6) 2021 and (b)(6) 2023).On (b)(6) 2021 medical records note the patient reports muscle spasms in the hip, thigh, and difficulty with ambulation.(b)(6) 2023 medical records note the patient has low back pain, difficulty with ambulation, right hip pain, and a sharp aching numbness pressure in the low back radiating out to the left hip while walking.The patient reports taking oral anti-inflammatory medication and having chiropractic manipulations and acupuncture to manage pain.The impression from the doctor was that the patient had levorotarory scoliosis with some degeneration and spondylosis of the lumbar spine and is status post hip replacement surgery.

Event Description

Medical records received.Physical therapy lower extremity functional scale survey results in (b)(6) 2016 indicate a marked disability in running, lifting heavy items, or performing heavy activities around the home.The patient walks with the assistance of a cane.The patient indicated in the survey she has a medical history of obesity, hypertension, arthritis, and osteoporosis, and has a pacemaker implanted, as well as bilateral total hip replacements.It was reported that the primary right hip had been implanted in 2006, and the left hip had been implanted in (b)(6) 2016.This information precedes the current right hip adverse event and revision.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device was not returned to depuy synthes for evaluation, however photos were provided for review.Review of the provided photos revealed that complaint condition cannot be confirmed since the device is not clearly shown in the evidence provided.No evidence of fracture of the implant was observed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Event Description

Medical records detail the primary operation that occurred on (b)(6) 2005.The patient did not sustain any intraoperative issues, however, developed a dvt post-operatively on (b)(6) 2005 which was captured in (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8089489
• MDR Text Key: 127890401
• Report Number: 1818910-2018-76042
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295178187
• UDI-Public: 10603295178187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2009
• Device Model Number: 56-3514
• Device Catalogue Number: 563514
• Device Lot Number: 1209556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 11/28/2018; 02/24/2020; 07/06/2020; 02/04/2021; 05/12/2021; 09/06/2022; 11/03/2022; 03/30/2023; 05/09/2023; 06/05/2023; 06/05/2023
• Supplement Dates FDA Received: 11/28/2018; 03/17/2020; 07/07/2020; 02/25/2021; 05/13/2021; 09/15/2022; 11/04/2022; 04/18/2023; 05/09/2023; 06/05/2023; 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MARATHON LINER 28/50 0-DEGREE; NEUTRAL HEAD 20-MM COBALT-CHROME; PINN MAR NEUT 28IDX50OD; PINNACLE SECTOR II CUP 50MM; PINNACLE SECTOR II CUP 50MM; PROXIMAL SLEEVE 14B LARGE; S-ROM*HEAD FEMORAL COCR 28+0; S-ROM*SLEEVE PRX ZTT, 14B-LRG; SROM*STM ST,30+4L NK,14X09X130
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Race: White