MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL PINNACLE; METAL ACETABULAR LINER

Catalog Number UNK HIP ACETABULAR LINER METAL

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Distress (2329); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/03/2011

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

Pinnacle litigation records received.Litigation records alleges pain, injury, emotional distress, tissue and bone destruction, wear and excessive amounts of cobalt and chromium.Doi: 2005.Dor: (b)(6) 2011; left hip.Please see (b)(4) right hip.

• Brand Name: UNK HIP ACETABULAR LINER METAL PINNACLE
• Type of Device: METAL ACETABULAR LINER
• 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 dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11681606
• MDR Text Key: 245893821
• Report Number: 1818910-2021-08156
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• 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 METAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2021
• 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
• Treatment: UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention