MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM HEAD FEMORAL COCR 32+9; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	87-5956
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.
Event or Problem Description
Litigation record received.Litigation alleges that the patient underwent right hip closed reduction on (b)(6) and (b)(6) 2017 due to dislocation.Doi: (b)(6) 2017, dor: (b)(6) 2018, right hip (third revision).
Additional 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.
Event or Problem Description
The patient had a revision right total hip arthroplasty to address failed right revision.The indication for surgery included multiple revisions including a cup-cage for discontinuity.The patient has been dislocated for 5 months.The head/liner were revised.Depuy femoral head was implanted along with a competitor liner.
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.H10 additional narrative: added: a2 (birth date, age), a3, b5, b7, d2b, d4 (procode,lot,exp,udi), d10 and h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1, d1, d2, d10 and g1.

• Brand Name: S-ROM HEAD FEMORAL COCR 32+9
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 10975900
• Report Number: 1818910-2020-26574
• Device Sequence Number: 4143045
• Product Code: JDI
• UDI-Device Identifier: 10603295218869
• UDI-Public: 10603295218869
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K920317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 87-5956
• Device Catalogue Number: 875956
• Device Lot Number: 8158351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 04/21/2022; 05/13/2022
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 05/10/2022; 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2015
• 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: (2) ZIMMER BONE CEMENT; 8 ZIMMER BONE SCREWS; S-ROM HEAD FEMORAL COCR 32+9; SROM*STM ST,36+8L NK,18X13X160; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM; ZIMMER CUP; ZIMMER LINER; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female