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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	09/04/2020
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
Patient was dealing with some dislocation issues.Surgeon had performed their initial operation about 20 years prior, but was unable to give me the exact date.The charting did not go back that far.Surgeon believed the patient was dealing with instability due to poly wear and cup positioning.Back then, surgeon would use our srom stem and femoral heads, but implanted competitor acetabular components.He removed the 28mm +0 head, and removed a 52mm competitor cup.Surgeon reamed the acetabulum up to 58mm and implanted a 58mm gription multi-hole cup.He opted for the 58x36mm neutral liner.A trial reduction was performed with a 36 +0 head and found to be satisfactory.The real head was opened and implanted.The closing process began.Doi: 20 years prior, dor: (b)(6) 2020, affected side: left side.
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: 10554266
• Report Number: 1818910-2020-20471
• Device Sequence Number: 2445473
• 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): 09/04/2020

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?: 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: 09/04/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/27/2020
• 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: 52MM STRYKER VITALOCK CUP; SROM STEM; 52MM STRYKER VITALOCK CUP; SROM STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 88