MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSYS EPOCH FULLCOAT FEMORAL STEM BEADED NECK TAPER; PROSTHESIS, HIP

Catalog Number 00408801206

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Host-Tissue Reaction (1297); Ossification (1428); Necrosis (1971); Pain (1994); Local Reaction (2035); Tissue Damage (2104); Osteolysis (2377)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 00620005622 / shell / lot #60890227, item# 00630505636/liner / lot # 60912579, item # 00801803602/ head /lot # 60906758, item #00625006535/bone screw/ lot #60884335.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2020 -00049, 0001822565 -2020 -00406, 0001822565 -2020 -00407.

Event Description

It was reported the patient underwent a total hip arthroplasty.Subsequently, the patient underwent a hip revision surgery approximately 10 years post implantation due to pain, elevated metal ion levels, trunnion wear, metallosis, and pseudotumor.During the revision extensive tissue damage, bone necrosis and trunnionosis was noted.Further, the surgeon noted extensive black corrosion around the head/neck junction, the posterior wall of the acetabulum had been significantly damaged by the pseudotumor, and heterotopic bone anterior to the cup.The shell, head and liner were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6.Reported event was confirmed by op notes.Revision op notes dated 12 jun 2018 demonstrated that the patient was revised due to pain, elevated metal ion levels, metallosis, and pseudotumor.During the revision, extensive tissue damage, bone necrosis, and trunnionosis was noted.Acetabular component noted to be malpositioned in abduction.Complete loss of abductors with extensive tissue necrosis.No bone bleeding consistent with bone necrosis.Femoral component well fixed and left in place.Posterior wall of the acetabulum had been significantly damaged by the pseudotumor.Heterotopic bone anterior to the cup noted.The shell, head, and liner were replaced without further complication 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: VERSYS EPOCH FULLCOAT FEMORAL STEM BEADED NECK TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9653108
• MDR Text Key: 177215218
• Report Number: 0001822565-2020-00408
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 00408801206
• Device Lot Number: 60846884
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention