MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-T M/H RDL SOL/SHL SZ41/54; PROTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Metal Related Pathology (4530)

Event Date 01/23/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: cat# 15-105004, lot# 017870, m2a-taper liner sz 41/32.Cat# 11-163669, lot# 328100, 32mm m2a mod head std nk.Cat# 103800, lot# 410280, tprlc reg por fmrl 7.5x135.Product will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00373, 0001825034-2024-00371, and 0001825034-2024-00374.

Event Description

It was reported that approximately 23 years post implantation of a right total hip arthroplasty, the patient was revised due to asymptomatic presentation of elevated metal ion levels.During the revision, trunnionosis was identified upon removal of the femoral head from the stem.The acetabular component was well-fixed but was revised to allow for additional anteversion.The initial stem was retained.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no related deviations or anomalies during manufacturing.A review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Revision op note.Patient presents asymptomatic ¿but metal ion levels had not normalized¿.Black synovial tissue encountered, no evidence of infection.Trunnionosis identified after removal of the femoral head, no trunnion damage.Acetabular component well fixed but removed, ¿new component was placed using computer navigation with similar inclination to previous hip but with the addition of approximately 10 to 15° of additional anteversion.2mm of leg length added per patient request and preop planning.Competitor shell, screws, and liner placed with zb head, initial stem left in place.Satisfactory stability, rom, and leg length achieved.No intraop complications, posterior approach.A definitive root cause cannot be determined.Event is confirmed via medical records.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.

Event Description

No additional event information to report at this time.

• Brand Name: M2A-T M/H RDL SOL/SHL SZ41/54
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18677007
• MDR Text Key: 335020435
• Report Number: 0001825034-2024-00372
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/09/2024

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 Model Number: N/A
• Device Catalogue Number: 15-104084
• Device Lot Number: 328040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female