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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 STD MITCH TRH CUP SIZE 52/58 HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS, INC. 1818910 STD MITCH TRH CUP SIZE 52/58 HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number MAC99885258
Device Problem Naturally Worn (2988)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 07/21/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Investigation summary: the original investigation report copied from (b)(4). The complaint states it was reported that there was a revision of mitch head. A complaints search and review of manufacturing records did not identify any anomalies. Without further information the root cause of the complaint cannot be determined. The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis. If further information is received the complaint shall be reopened and investigated further. Post market surveillance is per sep 419. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Records alleges metal debris and soft tissue reaction. Doi: (b)(6) 2009. Dor: (b)(6) 2016; left hip.
 
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Brand NameSTD MITCH TRH CUP SIZE 52/58
Type of DeviceHIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11594698
MDR Text Key243111311
Report Number1818910-2021-06585
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation
Type of Report Initial
Report Date 08/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMAC99885258
Device Lot NumberFM063475
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/31/2021 Patient Sequence Number: 1
Treatment
MITCH TRH MODULAR HEAD 52 +4 NECK; STD MITCH TRH CUP SIZE 52/58
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