MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 58ODX52ID; PROSTHESIS, HIP

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Host-Tissue Reaction (1297); Local Reaction (2035); Swelling (2091)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 157452, m2a-magnum mod hd sz 52mm, 220570.103209, taperloc por fmrl 17.5x155, 823640.139268, m2a-magnum 52-60mm tpr ins std, 532050.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 02977, 0001825034 - 2020 - 02978, 0001825034 - 2020 - 02979.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.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 underwent a left hip revision approximately 11 years post implantation due to altr, swelling, in-vivo corrosion and implant wear.During the procedure the biomet magnum sleeve was found to be cold fused to the trunnion of the biomet taperloc stem.Thickened pseudocapsule was noted and large effusion which was non-purulent.Some black corrosive material was noted within the synovium consistent the metal-on-metal bearing and metal wear debris.The biomet magnum femoral head and sleeve were noted to be cold fused to the trunnion of the taperloc stem.Minimal corrosion was noted after appropriate cleaning of the trunnion.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Reported event was confirmed via medical records and radiographs that were reviewed by a health care professional.Review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event for the insert.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: M2A-MAGNUM PF CUP 58ODX52ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10338268
• MDR Text Key: 201204866
• Report Number: 0001825034-2020-02976
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• 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: 09/24/2020

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: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: US157858
• Device Lot Number: 829560
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention