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 Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032)

Event Date 10/21/2021

Event Type  Injury  

Event Description

I am writing to you in regards to serious issues i have experienced with my depuy pinnacle hips.I underwent right and left hip replacements in 2006-2007, respectively.For the past several years i have suffered from pain and limited mobility.My doctor determined that my hips had failed and that i needed to undergo replacements ¿ which i did in 2020.I also discovered that i have been suffering from ¿metalosis¿ from the hip components wearing on each other.I understand there has been litigation surrounding the same hip products that i had and that j&j resolved many of those claims.I am writing to request that j&j open a claim and review and fairly resolve this matter.Upon your request, i am prepared to submit relevant medical records.I have also had the hips preserved by a medical storage facility if it is helpful to inspect them.I look forward to your acknowledgment and response.Doi: 2006, 2007; dor: 2020; left hip.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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 46581-0988 ; 6107428552
• MDR Report Key: 12769784
• MDR Text Key: 280448943
• Report Number: 1818910-2021-24569
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• 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: 10/21/2021
• 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
• Treatment: UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention