MAUDE Adverse Event Report: ZIMMER BIOMET, INC. XLPE LINER ELEVATED RIM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Unstable (1667); Separation Failure (2547); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Pain (1994); Local Reaction (2035); Scar Tissue (2060); Tissue Damage (2104); Excessive Tear Production (2235); Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ref 00620205622 lot 61729020 tm shell 56mm, ref 00771101210 lot 61719232 m/l taper stem 12.5, ref 00801803202 lot 61738898 versys femoral head 32mm+0.Multiple mdr reports were filed for this event, please see associated reports 0002648920-2019-00814, 0001822565-2019-04294-1, 0002648920-2019-00818.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient was revised due to instability, pain, limp, recurrent dislocations, and elevated metal ion levels.During the revision procedure, extensive tissue damage, calcar erosion, and necrosis was noted with associated tendon tear.Corrosion was noted about the head and neck trunnion.The head and liner were exchanged without complication, and the tendon tear was repaired with a suture anchor.Attempts were made to obtain additional information; however, none was available.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Reported event was confirmed by review of medical records noting postop diagnosis of a failed right hip with instability, pain, limp, likely altr from cobalt toxicity with associated gluteus medius tendon tear/necrosis.Five recent dislocations were noted, 2 posterior and 3 anterior.Interval between medius and tfl quite scarred.Necrotic hip capsule noted, large amount of yellow fluid expressed.Large amount of denuded femoral calcar poximally.Characteristic black signs of corrosion on the neck were evident.The locking mechanism noted to be fixed and could not be moved.Shell was well-fixed and in good position with some loss of soft tissue and bone posterior superiorly.Marginally viable capsule left for repair, gluteus medius had been noted to be torn from the necrotic appearing bone on the greater trochanter near complete tear with viable muscle but marginally viable bone.Dhr was reviewed and discrepancies were found.A definitive root cause cannot 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.

• Brand Name: XLPE LINER ELEVATED RIM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9288386
• MDR Text Key: 165372501
• Report Number: 0001822565-2019-04772
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K990135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 00631005832
• Device Lot Number: 61253479
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 02/24/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention