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

Model Number	52-3292
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Weakness (2145); Test Result (2695); No Code Available (3191)
Date of Event	10/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Occupation: legal.
Event or Problem Description
Patient was revised to address right hip nodular metal-on-metal total hip arthroplasty with adverse local tissue reaction and possible metal toxicity and right hip gluteus medius insertional tendon tear.Patient has developed right hip pain, abductor weakness, and associated limp.Physical exam and imaging studies have raised suspicion for probable abductor insertional tendon tear.Laboratory studies showed that patient had elevated serum metal ion levels with cobalt greater than 8 and chromium greater than 4.Operative notes stated that upon entry into the joint, there was expression of a scant amount of thick straw-colored fluid with multiple debris particles.The fluid was sent for histopathologic analysis which demonstrated absence of neutrophils but a significant amount of a cellular debris.Periprosthetic soft tissues were noted to be grossly normal-appearing and that there were no obvious signs of infection or necrosis.A representative sample of synovium was sent for histopathologic analysis which again demonstrated a significant scarcity/relative absence of neutrophils.These findings, combined with preoperative negative serologic indices effectively rule out periprosthetic infection.There was noted to be some dark metal staining of the trunnion but it was easily brushed off with the lap sponge and the trunnion was grossly intact appearing.Anteriorly, the gluteus minimus tendon and anterior one half of the gluteus medius tendon were intact to bone.However; the posterior one half of the gluteus medius tendon was found to be torn and mildly retracted away from the greater trochanter.Doi: (b)(6) 2009 - dor: (b)(6) 2018 (right hip).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9843362
• Report Number: 1818910-2020-08269
• Device Sequence Number: 740513
• Product Code: JDI
• UDI-Device Identifier: 10603295170976
• UDI-Public: 10603295170976
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: 52-3292
• Device Catalogue Number: 523292
• Device Lot Number: 2765875
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR