MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,30+4L NK,16X11X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 56-3516

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Deformity/ Disfigurement (2360); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> 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.---------------------------------------------- per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.Monitor ¿ exempt per wi-7915 - known possible complication of joint replacement surgery.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 part/lot number was not provided.The reported event is considered one of the possible complications of joint replacement.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specifications.The device associated with this event was used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No evidence was found indicating product error was a contributing factor.The need for corrective action was not identified.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot
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> a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle litigation records received.Patient was revised was due to heavy metal poisoning.Also alleges pain, injuries, metallosis, metal wear, loss of mobility, tissue destruction, limited daily activities, scarring and disfigurement.Doi: (b)(6) 2008 dor: (b)(6) 2021 unk hip.

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.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.H10 additional narrative: added: b5, b7, a2 (dob, age), a3, a5, d4 (lot, udi), g4 (pma), h4 corrected: a1, d1, d2a, db, d4 (catalog), d10, h6 (clinical and medical device problem code).

Event Description

Medical records were received and stated the following: the patient was revised to address osteolysis, metallosis, elevated metal ions, pain, crepitus in the hip.Operative note reported there was a gross egress of cloudy fluid consistent with metallosis, large defect of the capsule and external rotators.The abductor were completely necrotic and bone was gray and necrotic.There was corrosion in the femoral head and trunnion, extensive soft tissue muscular damage.Doi: on (b)(6) 2008, dor: on (b)(6) 2021, left hip.

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, b6, b7, d4 (expiry), d10 concomitant, h6 health effect - clinical code.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 the medical record, the patient had elevated metal ion, pain, and crepitus in the hip.Revision notes stated that there was a gross egress of cloudy fluid consistent with metallosis.The abductors were completely necrotic.The head was noted to be corrosion as well as the trunnion.Mri showed joint effusion and synovitis within the pseudo capsule dehiscing into the trochanteric bursa.The abductor cuff was noted to be torn.The patient gets pain when walking, bending, and squatting.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary :pinnacle litigation records received.Patient was revised was due to heavy metal poisoning.Also alleges pain, injuries, metallosis, metal wear, loss of mobility, tissue destruction, limited daily activities, scarring and disfigurement.Doi: (b)(6) 2008 dor: (b)(6) 2021 unk hip.The product was not returned to depuy synthes, however photos were provided for review.From pages and attachments"550-551 under file name (b)(4).Medical records ad (b)(6) 2023 (2) (2).Pdf; page 13-15, 18-26, 52,66 under file name (b)(4).Medical records ad (b)(6) 2023 (1) (2).Pdf; page 10 under file name (b)(4).Medical records ad (b)(6) 2023 (1) (3).Pdf; and pages 236- 239, 241-245, 257-259, 263-280 under file name (b)(4).Medical records ad (b)(6) 2023 (1) (5).Pdf" all available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed as the observed condition of the [srom*stm st,30+4l nk,16x11x150] would not contribute to a complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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 received.On (b)(6) 2013 consultation report stated patient plans to have a right total hip arthroplasty on may 6 due to progressive osteoarthritis (no pc required).On (b)(6) 2020 mri was reported to show left hip joint effusion and synovitis with pseudocapsule dehiscing into the trochanteric bursa.February 28th note increased cobalt 6.6 and chromium 7.1.(page 1382 of 6668).On (b)(6) 2021 the patient had a left hip revision to address osteolysis, elevated metal ion levels, pain, crepitus, and metallosis.The surgeon observed that the abductors and bone were necrotic there was corrosion noted on the femoral head as well as the trunnion.The trunnion was cleaned off.A depuy pinnacle constrained +4 liner, and a 28+ 0 biolox delta ceramic femoral head were implanted during this procedure.(surgery page 1333 of 6668).On (b)(6) 2021 patient notes redness and itchiness around the incision site.On (b)(6) 2022 patient had a left hip revision to address dislocation and pain.During the procedure, the surgeon observed significant evidence of residual metal debris and there was clearly evidence of polyethylene wear.It was noted that there was evidence of wear on the ceramic from where the hip had dislocated causing abrasion and loss of the ceramic coating.Depuy components were implanted during this procedure (surgery 1417 and 5548).On (b)(6) 2023 medical records note that the patient reports elevated blood pressure, palpitations, chest pressure, weakness, and fatigue.Shortness of breath.Patient also reports that her kidneys are failing, and patient has ¿chromium in her blood from her hip¿.

• Type of Device: S-ROM HIP SYSTEM : 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: kara ditty-bovard ; 1210 ward av; west chester, PA 19380 ; 6107428552
• MDR Report Key: 13005200
• MDR Text Key: 285645744
• Report Number: 1818910-2021-27916
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295178194
• UDI-Public: 10603295178194
• 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,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Model Number: 56-3516
• Device Catalogue Number: 563516
• Device Lot Number: 2726798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX15MM; PINN MULTIHOLE W/GRIPTION 50MM; PINNACLE MTL INS NEUT36IDX50OD; S-ROM M HEAD 36MM +0; S-ROM*SLEEVE PRX ZTT, 16B-LRG; SMARTSET GMV 40G US EO; SROM*STM ST,30+4L NK,16X11X150; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM; ZIMMER; ZIMMER; ZIMMER
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White