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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Tissue Damage (2104); Weakness (2145); Injury (2348); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary.No device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Initial reporter occupation: lawyer.(b)(4).

Event Description

Pinnacle medical records received.After review of medical records, the patient was revised due to wear of articulating bearing surface.Clinic visit reported of pain, trouble walking, discomfort, tenderness, inflammation, weakness and workup revealed abnormal soft tissue reaction around the hip.Operative note reported, there was scarring of the short external rotators of the posterior capsule.Dark stained synovial fluid tissue and fluid was noted and evidence of adverse local soft tissue reaction.The cup was well fixed and decided to retain it.There was extensive caseating material in the proximal femur and there was hypertrophic synovium, with dark staining of the tissues, as well as caseating material in the pubis and the ischium.Laboratory result for cobal and chromium were below 7 ppb.Doi: (b)(6) 2009; dor: (b)(6) 2019; left hip.

• 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10550004
• MDR Text Key: 207501177
• Report Number: 1818910-2020-20426
• Device Sequence Number: 1
• Product Code: KWA
• 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
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR