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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ASR ACETABULAR CUPS 52 PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

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DEPUY ORTHOPAEDICS, INC. ASR ACETABULAR CUPS 52 PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) Back to Search Results
Catalog Number 999800752
Device Problem Loss of Osseointegration
Event Type  Injury  
Event Description

Bilateral hip patient claims he experienced pain and a creaking/snapping feeling in his hip replacement. He further reports that the hip replacements required revision because the x-rays showed that the asr hips didn't seat properly. Surgery dates unk at this time.

 
Manufacturer Narrative

The devices associated with this report were not returned. Review of the device history records and/or a lot specific complaint database search was not possible as the lot codes required were not provided. The investigation could not draw any conclusions regarding the reported event with the information available. Based on the inability to identify a root cause, the need for corrective action was not indicated. Depuy considers the investigation closed at this time. Should the product and/or additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

 
Manufacturer Narrative

The asr platform was voluntarily recalled from the market in (b)(6) 2010, and the asr product codes are now considered inactive. Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions. (b)(4). Depuy considers the investigation closed at this time. Should the product or additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

 
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Brand NameASR ACETABULAR CUPS 52
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic dr.
warsaw IN 46581 098
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic dr.
warsaw IN 46581 098
Manufacturer Contact
katherine seppa, mgr.
700 orthopaedic dr.
warsaw , IN 46581-0988
5743727333
MDR Report Key1694539
Report Number1818910-2010-03162
Device Sequence Number1
Product CodeKWA
Report Source Manufacturer
Source Type Other
Reporter Occupation UNKNOWN
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 04/29/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/18/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number999800752
Device LOT Number2206546
Was Device Available For Evaluation? No
Date Manufacturer Received04/29/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/12/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1749/1816-2011

Patient TREATMENT DATA
Date Received: 05/18/2010 Patient Sequence Number: 1
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