MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-TAPER LINER SZ 41/32; PROSTESIS, HIP

Catalog Number 15-105004

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 05/18/2021

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 location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 11-163668/ 32mm m2a mod head / lot # 036960.Item# 162253/ bi-metric porous fmrl/ lot# 709910.Item# 10-104058/ m2a-t m/h rad 2hl shl / lot # 135750.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -01692.

Event Description

It was reported that patient underwent left hip revision surgery 19 years post implantation due to elevated cobalt levels and pain.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported that patient underwent left hip revision surgery 19 years post implantation due to elevated cobalt levels and pain.No further event information available at the time of this report.

Manufacturer Narrative

Cmp-(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp)mmi review: impressions: ovoid-shaped well-marginated zone of lucency surrounding portions of the acetabular cup.This could be related to the event/deficiency description metal ions and metallosis.There is increased lateral inclination of the cup and this could be intentional based on surgical technique.Positioning does increase possibility of hip dislocation, which is not evident currently.If this is a new finding (based upon comparison to prior examinations), then positioning of the cup since prior time point could be related to loosening as a result of metallosis, but this is not confirmed based upon current imaging.Device history record (dhr) was reviewed and no discrepancies 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 d10: item # 11-163668/ 32mm m2a mod head / lot # 036960 item# 162253/ bi-metric porous fmrl/ lot# 709910 item# 10-104058/ m2a-t m/h rad 2hl shl / lot # 135750 multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -01692.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined this component did not contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined this component did not contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: M2A-TAPER LINER SZ 41/32
• Type of Device: PROSTESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11934469
• MDR Text Key: 254261357
• Report Number: 0001825034-2021-01693
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• PMA/PMN Number: K042841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2012
• Device Catalogue Number: 15-105004
• Device Lot Number: 065540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10; SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention