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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2009

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

"literature article entitled, ¿migration and wear of the duraloc ¿1200 series¿ cup associated with enduron uhwmpe using the ebra method and the imagika software¿ by thierry thirion, et al, published by hip international (2010), vol.20, no.2, pp.198-203, was reviewed.The purpose of this study was to assess the migration of the duraloc ¿1200 series¿ cups and to correlate migration with polyethylene wear.Implanted depuy products: (186) duraloc 1200 acetabular cup with locking ring, (186) enduron liner, (17) cocr femoral head paired with a charnley elite stem.Results: there were no reported product problems with the implanted depuy stems and heads.1 cup and liner revision due to migration of the cup secondary to osteolysis.There was no evidence of polyethylene wear upon examination of the explanted liner.There was an unknown number of mispositioned and migrated cups identified on progressive radiographic studies.There were no patient consequences or clinical symptoms associated with the radiographically identified cup mispositioning and migration.There was an unknown number of polyethylene liner wear identified on progressive radiographic studies.There were no patient consequences or clinical symptoms associated with the identified polyethylene wear.Captured in this complaint: duraloc cup: implant migration; serious injury, medical device removal, and surgical intervention.Enduron liner: no reported product problem; medical device removal, surgical intervention, and osteolysis.Duraloc cup: mispositioned, implant migration.Enduron liner: implant bearing wear.No patient consequences, no clinical signs, symptoms, or conditions.".

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP 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
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9606802
• MDR Text Key: 192226030
• Report Number: 1818910-2020-02245
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2020
• 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 Sequence Number: 1