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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP ACETABULAR LINERS

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problems Pain (1994); 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 entitled "mechanical failure of marathon cross-linked polyethylene acetabular liner after total hip arthroplasty". Literature article entitled, "mechanical failure of marathon cross-linked polyethylene acetabular liner after total hip arthroplasty" by matthew o. Barrett, md, et al published in american journal of orthopedics (2011) vol. 40, no. 10, pp. 523-526, was reviewed for mdr reportability. This article documents a case of a retrieved marathon acetabular liner that had been fractured at the superior rim. A (b)(6) year-old female, weight (b)(6) lbs. , bmi 19. 6, underwent left primary tha due to severe hip dysplasia. She was implanted with a 46-mm pinnacle bantam acetabular cup with one dome screw, 28-mm marathon polyethylene liner, a femoral head, and s-rom femoral stem. Two years following primary tha, she presented with painful popping of the left hip and was referred for acetabular liner revision. Intraoperatively, the poly liner was found to be fractured at the anterosuperior margin. The head and the liner were exchanged while the cup and stem were well fixed and left in situ. Postoperative analysis of the liner revealed extensive wear on both sides of the liner indicating disassociation from the cup and fracture of the liner due to shearing of the locking mechanism tabs. At follow-up, the patient reported no further complications.

 
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Brand NameUNKNOWN HIP ACETABULAR LINERS
Type of DeviceHIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key8920324
MDR Text Key155183791
Report Number1818910-2019-101931
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type LITERATURE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received09/09/2019
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: 08/22/2019 Patient Sequence Number: 1
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