MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR CUP PINNACLE

Catalog Number UNK HIP ACETABULAR CUP PINNACL

Device Problem Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Physical Asymmetry (4573)

Event Date 01/01/2021

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.

Event Description

It was reported as " my mother-in-law was the recent recipient of a depuy synthes summit/pinnacle hip system, implanted roughly 3 months ago.I first heard the surgery had gone well.She had multiple complaints as of this thanksgiving weekend.Residual pain at the operation site, mostly due to post-op bleeding, but also due to implant positioning (according to her).Her operated leg is 7 mm shorter (verified by x-ray with another depuy surgeon dr.M.J.).I saw the x-ray and this is obvious to the naked eye.Post-op care and instruction was minimal and her attempts to get anyone to record her residual pain and limb length disparity were rebuffed until repeated attempts.After talking with her the usual pre-op preparations were not done (a-p and m-l x-rays, implant size templating),and also got no info on what to expect post-op, etc.She is so disappointed with the level of care she is complaining to cms about this (the surgeon post-op care).The devices themselves are working 'as intended' but are misaligned.I'm not sure if this qualifies as a complaint with the devices per se but she is definitely not satisfied with the outcome of her hip replacement.I've asked her for the name of the surgeon and the ids of the implants, but haven't heard back within the 24-hour complaint recording window.I should be able to update you tomorrow.".

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 manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK HIP ACETABULAR CUP PINNACLE
• Type of Device: HIP ACETABULAR CUP
• 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: 12960613
• MDR Text Key: 286666022
• Report Number: 1818910-2021-27503
• Device Sequence Number: 1
• Product Code: JDI
• 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,Followup
• Report Date: 11/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP PINNACL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1