MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 P.F.C.* 28MM HEAD +5 MM; PFC FEMORAL HEADS (10/12) : HIP METAL FEMORAL HEADS

Model Number	85-3834
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/21/2021
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 recurrent dislocator.Original surgery 2000.Pfc ultima cement stem sz 3m and competitor cup.Head and liner revised in 2020 for wear and stability.Current surgery, constrained liner cemented into and head replaced.Doi: (b)(6) 2020.Dor: (b)(6) 2021; unknown hip.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > no device associated with this report was received for examination.This device is known to have been used in conjunction with competitor manufactured products.This is considered off label use.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.
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.H10 additional narrative: added: b5.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 was received indicated that previous revision (b)(6) 2020 - 804810 and was head only depuy.Richards reflection cup.Wear was with richards liner no depuy ever used or implanted/explanted affected side - left side.

• Common Device Name: PFC FEMORAL HEADS (10/12) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11776805
• Report Number: 1818910-2021-09534
• Device Sequence Number: 3138184
• Product Code: KWY
• UDI-Device Identifier: 10603295207610
• UDI-Public: 10603295207610
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K893872
• 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,Followup
• Report Date (Section B): 04/21/2021

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: 85-3834
• Device Catalogue Number: 853834
• Device Lot Number: 8552607
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/17/2021; 06/02/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 05/28/2021; 06/03/2021
• 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: COMPETITOR; CONSTRAINED LINER; PFC ULTIMA CEMENT STEM SZ 3M; RICHARDS REFLECTION CUP (COMPETITOR); COMPETITOR; CONSTRAINED LINER; PFC ULTIMA CEMENT STEM SZ 3M; RICHARDS REFLECTION CUP (COMPETITOR)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR