MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 S-ROM*HEAD FEMORAL COCR 32+12; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	52-2034
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient's hip was revised back on (b)(6) 2020 by a surgeon at (b)(6).The case number for the mdr is 92249.During that revision, the srom head was changed from a 28mm to a 32mm head.The patient was implanted with a stryker cup, so the liner change was from a 28 to 32mm liner.Unfortunately, the hip was still dislocating and the surgeon felt the patient needed to have their acetabulum revised.He revised the cup to a zimmer biomet g7 dual mobility construct.He wanted to keep the srom stem and sleeve implanted, so he opted to use our 28mm femoral head with the dual mobility liner from zimmer biomet.A trial reduction was performed with a 28mm +9 head and found to be stable.The real implants were opened and inserted.The closing process began.Doi: (b)(6) 2020.Dor: (b)(6) 2021.Affected side: unknown 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, 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.Device history lot: the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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: 12246221
• Report Number: 1818910-2021-16475
• Device Sequence Number: 2840503
• Product Code: JDI
• UDI-Device Identifier: 10603295170846
• UDI-Public: 10603295170846
• 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 Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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: 52-2034
• Device Catalogue Number: 522034
• Device Lot Number: 9013909
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/24/2021
• 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: S-ROM*HEAD FEMORAL COCR 32+12; SROM SLEEVE; SROM STEM; STRYKER CUP; STRYKER LINER; S-ROM*HEAD FEMORAL COCR 32+12; SROM SLEEVE; SROM STEM; STRYKER CUP; STRYKER LINER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR