MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50MM TPR INSRT-3; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: m2a magnum 157450/ unk; m2a-magnum pf cup (b)(4) / unk; taperloc por fmrl 103204 / unk.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 - 2018 - 00063.

Event Description

It was reported that during a revision procedure, the femoral head and taper adapter could not be removed, the procedure was continued a week later and the components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

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.

Manufacturer Narrative

Ln - 330980, manufacture date - sep 11, 2006, expiration date - sep 30, 2016.Or ln: 156850, manufacture date - oct 15 2007, expiration date - oct 31, 2017.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).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: 0001825034-2021-01040.

Event Description

It was reported that patient experienced pain, dysfunction and limited range of motion after right total hip arthroplasty.Approximately 10 years later, the patient underwent a revision surgery which was aborted due to inability to disengage the head from the stem.The surgery was attempted a second time successfully about a week later.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.Medical records were reviewed and noted that the attempted revision was aborted due to inability to disengage the head and stem.Multiple attempts and over an hour spent trying to disengage the femoral head from the trunnion.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 42-50MM TPR INSRT-3
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7183922
• MDR Text Key: 97026021
• Report Number: 0001825034-2018-00062
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 139254
• Device Lot Number: 156850
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention