MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*HEAD FEMORAL COCR 28+9; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	87-5954
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that original implant date unknown.Patients hip was done several years ago by dr (b)(6) at (b)(6).Dr (b)(6) was unsure of the exact date.Patient was dealing with some dislocation issues.Dr (b)(6) felt the patient would benefit from a constrained liner.The 56x28 +4/10 degree liner and 28mm +9 head were removed.A +4 neutral constrained liner was trialed with a 36 +9 head.Hip was found to be stable and the real implants were opened and inserted.Closing process began.Doi: unk, dor: (b)(6) 2021 , right hip.
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.
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 ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13011388
• Report Number: 1818910-2021-28210
• Device Sequence Number: 1765872
• Product Code: JDI
• UDI-Device Identifier: 10603295218845
• UDI-Public: 10603295218845
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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: 87-5954
• Device Catalogue Number: 875954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX +4 10D 28IDX56OD; S-ROM*HEAD FEMORAL COCR 28+9
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Unknown