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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 PINNACLE METAL ACETABULAR LINER

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DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL PINNACLE METAL ACETABULAR LINER Back to Search Results
Catalog Number UNK HIP LINER METAL
Device Problem Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Metal Related Pathology (4530)
Event Date 09/30/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. (b)(4). 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 mom litigation record received. Litigation alleges heavy metal poisoning from toxic metals release by the pinnacle system resulting to metallosis, scar tissue formation, hip pain, metal wear and limited activities of daily living. Plaintiff also suffer from emotional trauma and distress seeking compensation for all the damages. Doi: (b)(6), 2009; dor: (b)(6), 2020; right hip.
 
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Brand NameUNK HIP ACETABULAR LINER METAL PINNACLE
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 Key12983116
MDR Text Key282100016
Report Number1818910-2021-27761
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP LINER METAL
Was Device Available for Evaluation? No
Date Manufacturer Received12/01/2021
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: 12/13/2021 Patient Sequence Number: 1
Treatment
UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM
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