MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 S-ROM*HEAD FEMORAL COCR 32+6; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	52-2033
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	09/22/2020
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 shell, liner, and head were revised for chronic dislocation.Shell implanted 2005/ head 2017.Doi: 2005 for the cup, 2017 for the head.Dor: (b)(6) 2020, affected side: left hip.
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.Patient code: no code available ((b)(4)) is used to capture joint instability.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received indicated that the patient was revised for instability unrelated to component position.
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.

• 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: 10639432
• Report Number: 1818910-2020-21680
• Device Sequence Number: 11505524
• Product Code: JDI
• UDI-Device Identifier: 10603295170839
• UDI-Public: 10603295170839
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 09/22/2020

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: 52-2033
• Device Catalogue Number: 522033
• Device Lot Number: 8010930
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/12/2020; 11/04/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 10/22/2020; 11/05/2020
• 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: SROM CUP; SROM MAR LNR L 32MM+3MM 10 DEG
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR