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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 Fracture (1260); Noise, Audible (3273)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 07/12/2016
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. (b)(4).
 
Event Description
The literature article entitled, "error in surgical technique causing ceramic acetabular liner fracture in primary total hip arthroplasty ¿ a report of two cases" written by narinder kumar and dr. Vyom sharma published by journal of arthroscopy and joint surgery 3 (2016) 75¿77 http://dx. Doi. Org/10. 1016/j. Jajs. 2016. 07. 001 on 12 july 2016 was reviewed for mdr reportability. The article reports on 2 cases with depuy implants that were discovered to have fractured ceramic liners and attributed to improper seating by previous surgeons based upon studies of the earliest follow up radiographs. Each case is captured individually on linked complaints. This complaint captures the first case of a (b)(6) year old male who received initial tha in left hip in may 2012. The identified products were depuy pinnacle acetabular cup, summit femoral stem biolox delta ceramic on ceramic bearing surfaces. He reported discomfort on full weigh bearing immediately and throughout follow ups with same complaints at 6 weeks post-operatively. At 3 months post op, his discomfort increased with occasional noise in left hip and consulted with another surgical team as he had relocated. Review of the earliest available post op images revealed a small fractured fragment and the liner incompletely seated "even at that stage. " the cup and stem were found to be well positioned. At revision, the liner was found fractured at its rim inferiorly with scratching of femoral head component. Both liner and head were changed for new ceramic on ceramic and at 2 years follow up he remains asymptomatic. The article attributes fault to prior surgeon's improper seating of liner.
 
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)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key9164929
MDR Text Key168466868
Report Number1818910-2019-107919
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/19/2019
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 Received12/06/2019
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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