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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR HA ACET CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US PINN SECTOR HA ACET CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-12-050
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 01/01/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Health effect - clinical code: (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
Revision surgery required due to luxation of the poly.Cup was revised because the head had been scratching against the cup.No surgical delay.Date of primary implantation: (b)(6) 2019 date of revision: (b)(6) 2021 operative side: right.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device and provided images found evidence to support disassociation of the liner from the cup while implanted.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
 
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Brand Name
PINN SECTOR HA ACET CUP 50MM
Common Device Name
PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12121028
Report Number1818910-2021-14307
Device Sequence Number11704395
Product Code LPH
UDI-Device Identifier10603295009153
UDI-Public10603295009153
Combination Product (Y/N)N
Initial Reporter CountryBE
PMA/510(K) Number
K031495
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number1217-12-050
Device Catalogue Number121712050
Device Lot NumberJ1686D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2021
Initial Date Received by Manufacturer 06/16/2021
Supplement Date Received by Manufacturer07/14/2021
Initial Report FDA Received Date07/06/2021
Supplement Report FDA Received Date07/15/2021
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
ALTRX NEUT 32IDX50OD; PINN SECTOR HA ACET CUP 50MM; UNKNOWN HIP FEMORAL HEAD; ALTRX NEUT 32IDX50OD; PINN SECTOR HA ACET CUP 50MM; UNKNOWN HIP FEMORAL HEAD
Patient Age77 YR
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