MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-T UNIV 2-HOLE SHL SZ 41/56; HIP PROSTHESIS

Model Number N/A

Device Problems Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Osteolysis (2377); Osteopenia/ Osteoporosis (2651); No Information (3190)

Event Date 01/25/2017

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.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 was 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.Concomitant medical products: item # unk, hip-mom-heads-unk, lot # unk, item # unk, hip-unknown-stems-unk, lot # unk.Multiple reports have been submitted for this event.Please see associated reports: 0001825034-2018-10142, 0001825034-2018-10143, 0001825034-2018-10144.

Event Description

It was reported that a patient was revised due to unknown reasons an unknown timeframe post implantation.Attempts have been made, and no further information has been provided.

Event Description

It was reported that a patient was revised approximately 12 years post implantation due to elevated ion levels, pain, corrosion, pseudotumor, malposition of cup, osteolysis and bone loss.Op notes indicated significant pain, elevated ion levels, and a pseudotumor.Other findings include: the cup is in an unacceptable angle, significant metal corrosion on the trunnion, upon removing the cup there was significant osteolysis and cavitary bone loss.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

Concomitant medical products: item # 11-163667, m2a-magnum mod hd, lot # 042600, item # 15-105004, m2a-taper liner, lot # 809170, item # 11-103205, ntegral/xlat por, lot # 895150.An additional report has been submitted for this event: 0001825034-2018-11302.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records stating patient experienced significant pain, elevated blood metal ions, osteolysis and pseudotumor.Corrosion was also noted to be found during the surgery along with malpositioning of the cup component.Dhr was reviewed and no discrepancies were found.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 additional event information to report at this time.

Manufacturer Narrative

Complaint sample was returned and evaluated against the reported event.Upon visual inspection the shell shows scuffing and some dried cement.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-T UNIV 2-HOLE SHL SZ 41/56
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8028124
• MDR Text Key: 125782342
• Report Number: 0001825034-2018-10143
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 15-103686
• Device Lot Number: 285850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2021
• 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