MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLVE ZTTOVSZ 20F-LRG18ID; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	55-0728
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Weakness (2145); Injury (2348); Osteolysis (2377); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530)
Date of Event	04/17/2018
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.Initial reporter occupation: lawyer.
Event or Problem Description
After review of medical records, the patient was revised due to adverse tissue response.Lab work showed an increase in cobalt chromium levels as she began having pain.Operative notes indicated that the patient had a large fluid-filled soft tissue mass over the greater trochanter and expansion of her trochanteric bursa.The bursa was filled with a cloudy white fluid consistent with that seen in metal wear reaction.There was a great deal of lytic wear debris spread throughout this large sac.The greater trochanter had areas of lysis, as did the medial neck.There was evidence of fretting corrosion on the taper.There were large areas of lysis present behind the cup.The large head ball was disimpacted from the taper and fretting corrosion was visible.Additionally, it was also reported that during the primary hip replacement surgery, a small crack occurred anteriorly in the neck during impaction of the stem, it was elected to pass a 2 mm cerclage cable around the femur to prevent crack extension.
Additional 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.Udi: (b)(4).
Additional 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.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9807006
• Report Number: 1818910-2020-07230
• Device Sequence Number: 19583985
• Product Code: LPH
• UDI-Device Identifier: 10603295175582
• UDI-Public: 10603295175582
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2024

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: 07/31/2010
• Device Model Number: 55-0728
• Device Catalogue Number: 550728
• Device Lot Number: 1890776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 03/18/2021; 06/17/2024
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 03/22/2021; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADAPTER SLEEVE 11/13 +0.; ASR ACETABULAR CUPS 54.; ASR UNI FEMORAL IMPL SIZE 47.; S-ROM*SLVE ZTTOVSZ 20F-LRG18ID.; SROM*STM ST,36+8L NK,18X13X160.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female