MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM TPR INSRT; PROSTHESIS HIP

Catalog Number 139256

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tissue Damage (2104); Reaction (2414); Metal Related Pathology (4530)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

Cmp (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Part# us157852/ m2a cup/ lot # 372780 part#157446/ head/ lot# 920470 part# 11-103205/ stem/ lot # 925960 multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00289 0001825034 -2020 -04090 0001825034 -2020 -04091.

Event Description

It was reported that the patient underwent a left hip revision surgery approximately 10 years post implantation due to pain, metallosis, and tissue damage.Attempts have been made and additional information is not available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was able to be confirmed by the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: painful metal-on-metal left hip with probable metallosis.Spinal anesthesia.Ebl ¿ 200 ml.Specimen: femoral head and one pathologic specimen for metallosis workup negative for infection.It was felt that the ongoing metallosis issue was the approximate cause of her symptoms.Immediately over the greater trochanter and remnants of external rotators that there was a darkened deep brown metallosis reaction.It was noted that there was a defect in the capsule and the prosthesis could be viewed.It was noted very minute metallosis on the trunnion.Femoral stem and acetabulum were well fixed.Deep brownish metallosis reaction was basically tattooed along the inner capsule.Any attempt to debride would remove critical capsule and put the patient at reis for dislocation.Hence the capsule was left intact.No intra-operative complications were noted.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: remove type of investigation code 4114 ¿ device not returned visual evaluation of the returned taper found tool marks imprinted on the exposed face of the insert.Light colored debris and scuffing was observed inside the taper.The 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: M2A-MAGNUM TPR INSRT
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11252277
• MDR Text Key: 229409368
• Report Number: 0001825034-2021-00290
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2022

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: 04/30/2020
• Device Catalogue Number: 139256
• Device Lot Number: 221880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 02/02/2021; 03/16/2022
• Supplement Dates FDA Received: 02/03/2021; 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10; SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female