MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 52-60MM TPR INSRT-6; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Remove (1528); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bone Fracture(s) (1870); Necrosis (1971); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: unknown month and day in 2007.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01847, 0001825034-2021-01848, 0001825034-2021-01855.

Event Description

It was reported that the patient underwent a revision procedure approximately 14 years post implantation due to increased pain, pseudotumor, and fracture of the greater trochanter.During the revision, significant necrosis, osteolysis, and acetabular bone defects were noted.The taper adapter was cold-welded to the stem but removed with metal cutting tools without damage to the trunnion so that the stem was left intact.All other components were replaced without difficulty.Cancellous bone chips and bone putty were used to rebuild the acetabular defects.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

This follow-up report is being submitted to relay additional information.The event was confirmed with medical records received.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.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.

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.D10: catalog#: us157862 m2a-magnum pf cup 62odx56id lot#: 856540; catalog#: 157456 m2a-magnum mod hd sz 56mm lot#: 054390; catalog#: x11-180319 bi-metric/x por nc lat 19x175 lot#: 912600.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified findings of the reported issues with no complications during the procedure.Device history record was reviewed and no discrepancies relevant to the reported event were found.

Event Description

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

• Brand Name: M2A-MAGNUM 52-60MM TPR INSRT-6
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12036776
• MDR Text Key: 257386964
• Report Number: 0001825034-2021-01853
• 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,Followup
• Report Date: 10/06/2021

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: 06/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 139264
• Device Lot Number: 769950
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 08/03/2021; 08/13/2021; 10/04/2021
• Supplement Dates FDA Received: 08/05/2021; 09/02/2021; 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.; UNKNOWN MAGNUM 62MM CUP.; UNKNOWN MAGNUM HEAD.; UNKNOWN MAGNUM STEM.
• Patient Outcome(s): Hospitalization; Required Intervention