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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Metal Shedding Debris (1804)

Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/23/2017

Event Type  Injury  

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.

Event Description

Litigation received.Litigation alleges implant friction and wear caused large amount of toxic cocr metal ions and particles released into the patient¿s blood, tissue and bone surrounding the implant resulting to inflammation, pain, discomfort, limited mobility and ambulation difficulties.Right hip.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7072516
• MDR Text Key: 93383746
• Report Number: 1818910-2017-50488
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention