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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 P.F.C.* 28MM HEAD +5 MM; PFC FEMORAL HEADS (10/12) : HIP METAL FEMORAL HEADS
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DEPUY INTERNATIONAL LTD - 8010379 P.F.C.* 28MM HEAD +5 MM; PFC FEMORAL HEADS (10/12) : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 85-3834
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Joint Laxity (4526)
Date of Event 11/09/2020
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 stability and pain due liner wear.Cup and liner are competitor products.Doi: (b)(6) 2000; dor: (b)(6) 2020; affected side: right hip.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).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 : per wi-3430, a manufacturing review (mre) is unlikely to add value to the complaint investigation regarding an allegation of pain.Mre not requested.
 
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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 Key10889647
Report Number1818910-2020-25320
Device Sequence Number3048814
Product Code KWY
UDI-Device Identifier10603295207610
UDI-Public10603295207610
Combination Product (Y/N)N
Initial Reporter StateIA
Initial Reporter CountryUS
PMA/510(K) Number
K893872
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2000
Device Explanted Year2020
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) 11/09/2020
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 Health Professional
Device Model Number85-3834
Device Catalogue Number853834
Device Lot NumberXLE-27
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/09/2020
Supplement Date Received by Manufacturer12/15/2020
Initial Report FDA Received Date11/24/2020
Supplement Report FDA Received Date12/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
COMPETITOR CUP (SMITH NEPHEW RICHARDS REFLECTION); COMPETITOR LINER(SMITH NEPHEW RICHARDS REFLECTION); P.F.C. 28MM HEAD +5 MM; COMPETITOR CUP (SMITH NEPHEW RICHARDS REFLECTION); COMPETITOR LINER(SMITH NEPHEW RICHARDS REFLECTION); P.F.C. 28MM HEAD +5 MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age79 YR
Patient Weight82
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