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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 300 ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US PINNACLE 300 ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-03-052
Medical Device Problem Codes Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 06/24/2021
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
It was reported that patient underwent revision acetabular surgery due to dislocation.Poly was found to have disassociated from acetabular cup resulting in wear to acetabular cup and metallosis in acetabular region.Acetabular primary cup was replaced with a pinnacle sector 56 cup and 40 x 56 neutral poly and 40mm +5 femoral head.It also indicated in der that there was loosening to a poly component with unknown interface.Doi: (b)(6) 2020.Dor: (b)(6) 2021; left 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 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: a device history record (mre) review, was not possible because the required lot code was not provided.
 
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Brand Name
PINNACLE 300 ACET CUP 52MM
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 Key12173754
Report Number1818910-2021-15282
Device Sequence Number13687251
Product Code LPH
UDI-Device Identifier10603295008651
UDI-Public10603295008651
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
P070026
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
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) 06/24/2021
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 Number1217-03-052
Device Catalogue Number121703052
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/24/2021
Supplement Date Received by Manufacturer08/04/2021
Initial Report FDA Received Date07/15/2021
Supplement Report FDA Received Date08/05/2021
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 +4 10D 36IDX52OD; ARTICULEZE M HEAD 36MM +5; PINNACLE 300 ACET CUP 52MM; ALTRX +4 10D 36IDX52OD; ARTICULEZE M HEAD 36MM +5; PINNACLE 300 ACET CUP 52MM
Outcome Attributed to Adverse Event Required Intervention;
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