MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 60 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Date 09/28/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: item# 00-6305-060-40 trilogy liner lot# 61680374; item# 00-7713-011-00 stem with kinectiv technology lot# 61735122; item# 00801804002 12/14 femoral head 0 x 40mm lot# 61769478; item# 00784801300 m/l taper kinective neck implant lot# 61710088.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 07059.

Event Description

It was reported that patient was revised approximately 4 years post initial implantation of left side due to adverse local tissue reaction.Head and liner were exchanged.Osteolysis noted on the posterior part of the femur between the bone and cup.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of op notes which indicated patient underwent revision of the left total hip due to corrosion and adverse local tissue reaction.Upon entering the wound, benign appearing fluid was found inn trochanteric bursa.There was a hole in the posterior capsular repair and fluid was leaking from the joint.Ethibond sutures were used to re-repair.The femoral head was removed and mild corrosion was noted inside the femoral head.Mild staining was noted on the modular neck.Multiple attempts were made to remove the neck but the neck did not disengage.Osteolysis was noted on the posterior part of the femur between the component and bone, around greater trochanter, and behind the acetabular component.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 60 MM O.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8205113
• MDR Text Key: 131700642
• Report Number: 0001822565-2018-07067
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2021
• Device Model Number: N/A
• Device Catalogue Number: 00620006022
• Device Lot Number: 61711455
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 90