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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 32MM PINN AB IN TR 50; HIP INSTRUMENTS : ACETABULAR TRIALS
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DEPUY ORTHOPAEDICS INC US 32MM PINN AB IN TR 50; HIP INSTRUMENTS : ACETABULAR TRIALS Back to Search Results
Catalog Number 221882750
Medical Device Problem Codes Naturally Worn (2988); Scratched Material (3020)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/16/2018
Type of Reportable Event Malfunction
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
Complaint not specific to one case.Surgeons complain that pinnacle poly trials are worn and used, scratches on them and screws worn out.
 
Additional Manufacturer Narrative
(b)(4).Investigation summary: no products were returned hence the complaint cannot be confirmed.Depuy synthes considers the investigation closed at this time.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
32MM PINN AB IN TR 50
Common Device Name
HIP INSTRUMENTS : ACETABULAR TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8021374
Report Number1818910-2018-73937
Device Sequence Number19170608
Product Code LXH
UDI-Device Identifier10603295101888
UDI-Public10603295101888
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/17/2018
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 Catalogue Number221882750
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/17/2018
Supplement Date Received by Manufacturer12/11/2018
Initial Report FDA Received Date10/30/2018
Supplement Report FDA Received Date12/12/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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