MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM NECK TAPER; PROSTESIS, HIP

Catalog Number 00771101200

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

Patient Problems Pain (1994); Local Reaction (2035); Synovitis (2094); Tissue Damage (2104)

Event Date 08/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803201- femoral head- 61542827; 00620205422- shell porous- 61465218; 00631005032- liner- 61515674; 00625006540-bone scr- 61504863.Customer has indicated that the product will not be returned to zimmer biomet for investigation as device location is unknown.The investigation is in progress.Once the investigation has been completed a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00732.

Event Description

It was reported patient underwent l hip revision approximately 8 years post implantation due to cobalt toxicity, thigh pain, and mri findings suggestive of altr.During the procedure, synovitis, altr, tissue damage and trunnion corrosion was noted, the cobalt chrome femoral head was removed and replaced.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D7: device remains implanted.Reported event was confirmed by review of medical records noting mri showing significant synovitis and likely altr from corrosion between head and trunnion.Cobalt levels were elevated.Patient experiencing thigh pain.There is clear yellow fluid found deep in the thickened capsule.Corrosion was found on and around the base of the trunnion.Dhr was reviewed and no discrepancies were found.Additional information does not change the outcome of the previous investigation.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 additional event information to report at this time.

• Brand Name: FEMORAL STEM NECK TAPER
• Type of Device: PROSTESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9171879
• MDR Text Key: 161697993
• Report Number: 0001822565-2019-04347
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 00771101200
• Device Lot Number: 61510532
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2020
• 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