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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); No Code Available (3191)
Date of Event	04/24/2020
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.
Event or Problem Description
It was reported that this patient came into surgeon's office recently with discomfort and instability in her right hip.X-ray revealed that the stryker acetabular cup was malaligned and the poly was most likely worn out.She had her hip replaced 20+ years ago where a srom stem and a stryker vitalok acetabular cup was implanted by a surgeon that was unknown.The hospital staff nor the surgeon knew who did the original surgery and have no previous records available for this patient.Surgeon replaces the srom femoral head and used a zimmer cup.The lot information for the explanted 28mm + 0 hip ball that was explanted was not legible.The lot # on the femoral stem was not legible.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.

• 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: 10033076
• Report Number: 1818910-2020-11811
• Device Sequence Number: 3117265
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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 Model Number: 52-2028
• Device Catalogue Number: 522028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 06/19/2020
• 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: HIP ACETABULAR CUP (COMPETITOR); HIP ACETABULAR LINERS (COMPETITOR); UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL STEM; HIP ACETABULAR CUP (COMPETITOR); HIP ACETABULAR LINERS (COMPETITOR); UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 78