MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A MAGNUM TAPER INSERT; PROSTHESIS, HIP

Catalog Number 139256

Device Problem Difficult or Delayed Separation (4044)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Tissue Damage (2104)

Event Date 06/11/2019

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.Concomitant medical devices: part # unknown / unknown head / lot # unknown; part # unknown / unknown cup/ lot # unknown; part #unknown / unknown stem/ lot # unknown.Reported event was unable to be confirmed due to limited information received from the customer.Medical records were provided and reviewed by a health care professional.Review of the available records identified (b)(6) 2019 revision of left tha revision of left tha, femoral component.Repair of extended trochanteric osteotomy.Hip pain with mri findings suggestive of pseudotumor secondary to mom.Previous posterior approach utilized rust-colored fluid encountered, extensive gray unhealthy tissue encompassed pseudotumor.Also involved the abductors and the short external rotators.All unhealthy tissue was debrided and some sent to pathology as well as taken for cultures.Outer diameter of the head was easily removed; however, the inner diameter sleeve was cold-welded and could not be removed despite numerous attempts.Therefore, an extended trochanteric osteotomy was performed.Lateral third of proximal femur was taken off in one fragment and stem was removed from intramedullary canal.Cerclage cables placed.Rom testing completed which demonstrated stability, limb lengths checked and satisfactory.Device history record (dhr) reviewed was unable to be performed as the lot number of the device involved in the event is unknown.Root cause is unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported patient underwent total hip arthroplasty 14 years post implantation duet to pain and pseudotumor.During the revision surgery surgeon noted rust colored fluid within the capsule, damage to tissue, including adductors and adductors.The product had cold welded which required an osteotomy to be performed to remove the stem and cerclage wires placed.

Event Description

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

Event Description

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

Manufacturer Narrative

Inspection of the returned device revealed the stem and taper insert remain assembled upon receipt.Yellow debris is present within the crease between the stem and taper insert.The exposed surface of the insert and stem are damaged.The distal end of the stem is gouged.The porous coating has been mashed and gouged.Foreign material is also stuck to the coating.The head is scuffed such that areas of the finish have become dull.The material around the rim of the head has been dinged.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not be determined.Additional information provided does not change the root cause 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.

• Brand Name: M2A MAGNUM TAPER INSERT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10055426
• MDR Text Key: 193405855
• Report Number: 0001825034-2020-02004
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2021

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: 11/30/2015
• Device Catalogue Number: 139256
• Device Lot Number: 859260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 03/05/2021; 05/03/2021
• Supplement Dates FDA Received: 03/18/2021; 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention