MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +9; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	1365-34-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Test Result (2695); No Code Available (3191)
Date of Event	01/21/2020
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.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.
Event or Problem Description
The patient was revised to address broken insert.There is little information that was provided for this surgery from the patient.Apparently he has undergone multiple revision hip surgeries but the patient couldn¿t remember how many or his last one.He thinks it was 5 years ago in boston.He had a long srom stem with a pinnacle constrained insert that was broken.Surgeon removed a bunch of synovial tissue and tissue that looked like it had metal debris in it.Surgeon stated at one point he had a metal on metal implant.I don¿t know any of the sizes or implants from previous surgeries or if this patient has ever had a mdr report done.We replaced constrained pinnacle liner and srom 36 metal head.Doi: 2014, dor: (b)(6) 2020, affected side: right hip.

• Brand Name: S-ROM M HEAD 36MM +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
• MDR Report Key: 9845594
• Report Number: 1818910-2020-08375
• Device Sequence Number: 741185
• Product Code: JDI
• UDI-Device Identifier: 10603295033523
• UDI-Public: 10603295033523
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120599
• 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
• Report Date (Section B): 03/07/2020

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: No Information
• Device Model Number: 1365-34-000
• Device Catalogue Number: 136534000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2020
• Initial Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 91