MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 S-ROM*HEAD FEMORAL COCR 28+0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	52-2028
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the surgeon performed this patient's primary hip procedure back in 1995.Patient was implanted with srom femoral components, but competitor acetabular components.This particular patient was suffering from hip instability, so the surgeon believed they would benefit from an acetabular revision.A 28mm +0 femoral head was removed from the srom stem, and the competitor acetabular component was removed as well.The patient's hip was reamed up and prepared for a 58mm gription multi-hole cup.A 58x36 +4 10 degree liner was implanted and a trial reduction was performed with a 36mm +3 head.The hip was found to be stable, so the real femoral head was opened and implanted.The closing process began.Doi: 1995, dor: (b)(6) 2021, affected side: right hip.
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 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.Device history lot : a device history record (mre) review, was not possible because the required lot code was not provided.

• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11602137
• Report Number: 1818910-2021-06757
• Device Sequence Number: 3621951
• Product Code: JDI
• UDI-Device Identifier: 10603295170792
• UDI-Public: 10603295170792
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K920317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 52-2028
• Device Catalogue Number: 522028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 04/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: S-ROM*HEAD FEMORAL COCR 28+0; SROM STEM; STRYKER VITALOCK ACETABULAR COMPONENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR