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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 ACETABULAR LINER METAL
Device Problem Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Deformity/ Disfigurement (2360); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Event Date 03/17/2021
Event Type  Injury  
Manufacturer Narrative
(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, 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. No device associated with this report was received for examination. The adverse symptoms alleged and product code reported is associated with the depuy metal on metal articulation. A complaint database search and/or device manufacturing (dhr) reviews will not be performed. Monitor ¿ exempt per (b)(4) - known possible complication of joint replacement surgery. Investigational inputs were requested as indicated per internal procedures for this failure mode. The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system. Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed. For this investigation, no immediate action was required as no alleged deficiency with the device(s) was identified. Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution. The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon. From the event information received, it was not possible to determine the relationship of the device to the reported event. No information received with this individual complaint indicated that a broader investigation or corrective action was necessary. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. Device history lot : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(6).
 
Event Description
Pinnacle litigation records received. Patient was revised was due to heavy metal poisoning. Also alleges pain, injuries, metallosis, metal wear, loss of mobility, tissue destruction, limited daily activities, scarring and disfigurement. Doi: (b)(6) 2008, dor: (b)(6) 2021, unk 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, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward av
west chester, PA 19380
6107428552
MDR Report Key13005031
MDR Text Key282327674
Report Number1818910-2021-27913
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,Consumer,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER METAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2021
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? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
Treatment
UNK HIP ACETABULAR LINER METAL PINNACLE.; UNK HIP FEMORAL HEAD METAL.; UNKNOWN HIP FEMORAL STEM.
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