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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL METAL ACETABULAR LINER

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DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL METAL ACETABULAR LINER Back to Search Results
Catalog Number UNK HIP ACET LINER METAL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Numbness (2415); Ambulation Difficulties (2544); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. 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, 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.
 
Event Description
Pinnacle litigation records received. Litigation records alleges pain, weakness, swelling, numbness, bone, loss of mobility, loss of range of motion, and walking difficulty. During clinic visit on (b)(6) 2013 patient underwent diagnostic blood testing and the cobalt and chromium levels were within normal levels. Another clinic visit on (b)(6) 2019 patient underwent diagnostic of a 3-phase bone scan which revealed loosening of the depuy pinnacle system which would confirm and validated, required for revision surgery. Doi: jan 31, 2013 : dor: none reported (left hip).
 
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Brand NameUNK HIP ACETABULAR LINER METAL
Type of DeviceMETAL ACETABULAR LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11476139
MDR Text Key239570743
Report Number1818910-2021-05025
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP ACET LINER METAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/12/2021 Patient Sequence Number: 1
Treatment
CORAIL SIZE 16 HIGH OFFSET COLLARLESS STEM; METAL FEMORAL HEAD 40MM; METAL LINER 48X50; PINNACLE CUP 40X56MM
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