MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ5 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-01-110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 06/09/2021

Event Type  Injury  

Event Description

Medical record received.Patient was implanted with pinnacle cup and metal head and liner last 2009 and using a depuy summit hip system.Patient experienced pain, metallosis, elevated metal ion, pseudotumors, swelling, metal debris, difficulty ambulation, stiffness, been constipated since the surgical procedure, difficulty transferring as well as doing adls, impaired rom, impaired gait, bursitis, decreased lumbar mobility, flexibility, and weakness.Patient had significant bone loss from trochanteric region of femur, as well as around portions of the acetabulum.Revision notes stated that a black gelatinous material was encountered upon entering the hip joint and alval lesions were deep to the acetabular implant.Cup, head, and liner were removed during the first revision of the left hip.Left doi: (b)(6) 2009 - dor: (b)(6) 2021 (left hip).

Manufacturer Narrative

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

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: h6 clinical code: inflammation (e2326) is used to capture bursitis and inflammation.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Left shoulder mri reveals rotator cuff tear.Patient experiencing shoulder pain and weakness.No indication of total joint devices within the shoulder.Primary notes (b)(6) 2009 indicates primary left total hip due to left hip arthritis.Procedure completed within any noted complications.Revision note (b)(6) 2021 indicates the patient received a revision of the left hip due to bone loss, metal debris, pseudotumor.Upon entering the joint, metallosis was encountered.Femoral bone defect and large pseudotumor behind the acetabular cup as well as bone defect were also identified.Joint was debrided and bone grafts were utilized to support the bone defects.Head, liner and cup were revised.Procedure completed within any noted complications.On (b)(6) 2021 pre-admission screening for the left total hip revision and debridement with cadaver bone, metallosis of cobalt / chromium in blood, pseudotumor.Patient was noted to be home with functional decline due to pain, swelling and weakness.This is an expected result from having a revision surgery 3 days prior.On (b)(6) 2021 occupational therapy assessment notes patient had an initial left tha in 2009, the patient reports, worsening pain, stiffness, impaired mobility prior to the left revision where there was debridement of metal debris.On (b)(6) 2021 physical therapy initial examination notes the patient is post revision, having pain, limited rom, strength deficits, gait abnormalities, difficulty with strength deficits, gait abnormalities, difficulty with stairs and discomfort with prolonged standing, walking and sitting.This is an expected result post recent revision.On (b)(6) 2021, patient reports pain, limited rom, and strength deficits.These are expected results post revision surgery within month and ½.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this complaint was received for examination.The photographs attached does not provide any evidence of a device nonconformance.No device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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.

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.H6 clinical code: swelling/edema (e2338) is used to capture both swelling and edema.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received indicated that the patient experienced discomfort, significant lesion in trochanter, osteolysis around the greater trochanter, limited range of motion.Patient had benign chronic synovitis and patchy necrotic synovium, and cadaver bone build up, and small amount of fluid.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.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 record notes that on (b)(6) 2021, the patient had depuy metal femoral head, depuy poly liner, competitor cement, depuy acetabular cup, depuy screws x2 implanted.On (b)(6) 2021 physical therapy, initial examination notes the patient is post revision, having pain, limited rom, strength deficits, gait abnormalities, difficulty with strength deficits, gait abnormalities, difficulty with stairs and discomfort with prolonged standing, walking, and sitting.This is an expected result post recent revision.On (b)(6) 2022, medical records note the patient is over one year post having a revision.The patient continues to have weakness in the leg but does not have pain.The patient reports having pancreatic cancer.There was no mention of correlation or allegation of the cancer being caused by implants or surgical procedure.

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.

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.

• Brand Name: SUMMIT POR TAPER SZ5 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15471315
• MDR Text Key: 300454435
• Report Number: 1818910-2022-18501
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059363
• UDI-Public: 10603295059363
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/22/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 1570-01-110
• Device Catalogue Number: 157001110
• Device Lot Number: C4RDG1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 09/06/2022; 11/03/2022; 01/23/2023; 01/23/2023; 02/23/2023; 05/15/2023
• Supplement Dates FDA Received: 10/03/2022; 11/04/2022; 02/08/2023; 02/10/2023; 02/24/2023; 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2008
• 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: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINNACLE 300 ACET CUP 50MM; PINNACLE MTL INS NEUT36IDX50OD
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female