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

Catalog Number US157848

Device Problems Material Erosion (1214); Malposition of Device (2616); Insufficient Information (3190)

Patient Problems Pain (1994); Local Reaction (2035); Tissue Damage (2104); Osteolysis (2377); No Information (3190)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device location is unknown.:concomitant medical products part #unknown / unknown head / lot # unknown.Part #unknown / unknown stem/ lot # unknown.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -01699.0001825034 -2020 -01700.

Event Description

It was reported the patient underwent a total hip arthroplasty on an unknown date.Subsequently, the patient's legal counsel is reporting the patient is experiencing unknown complications.However, no revision procedure has been reported to date.

Event Description

It was reported the patient underwent a hip revision surgery approximately 11 years post implantation due to pain and elevated metal ions.During the revision, altr from metal debris was noted.The stem was well-fixed and remained in place.All other components were replaced without complication.Head, taper and taper adaptor were revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: item # 157442/ m2a-magnum mod hd / lot # 058100 item# 139252/ m2a-magnum tpr insert/ lot # 367940 item # 103203/ taperloc por fmrl /lot # 604020.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records noting patient presented with worsening pain and elevated metal ion levels.A large fusion with substantial metal debris in the hip joint was found.The acetabular component was retroverted and unable to find stability with trials, so the cup was removed and replaced.Dhr was reviewed and no discrepancies were found.The root cause is 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.

• Brand Name: M2A-MAGNUM PF CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9976760
• MDR Text Key: 188190652
• Report Number: 0001825034-2020-01701
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: US157848
• Device Lot Number: 637700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention