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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problems Hypersensitivity/Allergic reaction (1907); Joint Dislocation (2374); Test Result (2695); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
An article/literature was received entitled "increased serum ion levels after ceramic-on-metal bearing total hip arthroplasty: influence of an asian lifestyle¿ update 18 sep 2019. ¿increased serum ion levels after ceramic-on-metal bearing total hip arthroplasty: influence of an asian lifestyle¿ was reviewed for mdr reportability. The study followed 404 primary total hip arthroplasties, including 258 ceramic-on-metal (com tha) and 146 ceramic-on-ceramic or ceramic-on-polyethylene (non-com tha). A pinnacle acetabular cup and summit cementless stem were used in both groups. The ceramic-on-metal operations used biolox delta modular head and ultamet liner while the non-ceramic-on-metal operations used a depuy head with either a depuy ceramic liner or marathon polyethylene liner. It is noted specific patient identifiers nor specific revision information was provided. The following adverse events were noted: dislocation occurred in 5 com tha and 2 non-com tha. All dislocations were corrected with closed reduction with no reported recurrence. 1 com tha patient complained of a noisy hip with no evidence of intervention. 1 com tha patient underwent a revision to address a pseudotumor. Multiple patients in each group developed elevated metal ion levels. There is no evidence of revision or intervention to address elevated levels.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
==
> no device was received. Root cause undetermined. 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameUNKNOWN HIP ACETABULAR LINERS
Type of DeviceHIP ACETABULAR LINERS
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 avenue
west chester, PA 46581-0988
6107428552
MDR Report Key9163530
MDR Text Key169845131
Report Number1818910-2019-108060
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2019
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: 10/07/2019 Patient Sequence Number: 1
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