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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 HA ACET CUP 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US PINNACLE 100 HA ACET CUP 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-11-048
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 03/08/2021
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
Revision hip on (b)(6) 2021, where a pinnacle acetabular poly liner was completely worn and delaminated.Primary surgery took place in 2014 at another (b)(6) hospital, the pinnacle shell and liner was revised.The primary femoral stem was a corail.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
PINNACLE 100 HA ACET CUP 48MM
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 Key12218003
Report Number1818910-2021-15872
Device Sequence Number4448176
Product Code LPH
UDI-Device Identifier10603295009047
UDI-Public10603295009047
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K031495
Number of Events Summarized1
Summary Report (Y/N)N
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) 03/08/2021
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 Number1217-11-048
Device Catalogue Number121711048
Device Lot Number520179
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2021
Initial Date Received by Manufacturer 07/20/2021
Supplement Date Received by Manufacturer07/29/2021
Initial Report FDA Received Date07/23/2021
Supplement Report FDA Received Date08/02/2021
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
APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 28MM +1.5; PINNACLE 100 HA ACET CUP 48MM; UNK HIP ACETABULAR LINER POLY PINNACLE; UNK HIP FEMORAL STEM CORAIL; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 28MM +1.5; PINNACLE 100 HA ACET CUP 48MM; UNK HIP ACETABULAR LINER POLY PINNACLE; UNK HIP FEMORAL STEM CORAIL
Outcome Attributed to Adverse Event Required Intervention;
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