MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50MM TPR INSRT-6; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Information (3190)

Event Date 07/19/2017

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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 139252, m2a-magnum 42-50mm tpr insrt-6, lot: unk.Part: 157444, m2a-magnum mod hd sz 44mm, lot: unk.Multiple mdr reports were filed for this event, please see associated reports: taper: 0001825034-2019-03125.Head: 0001825034-2019-03126.

Event Description

It was reported that during revision surgery, the metal head would not disengage/release from the trunnion during explanation.It was completely incarcerated on the trunnion.You could see black corrosive material around it.Multiple methods were used, head finally released from the trunnion.The process took a full hour to get the head and adapter off.Extensive corrosion was noted.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

The event was confirmed with medical records received.Initial op notes demonstrated that the patient had right tha due to severe degenerative arthritis.Revision op notes observed the patient was revised due to pain, noise, and elevated metal ions.During the revision procedure, it was noted that a pseudotumor with extensive tissue damage and osteolysis was present in conjunction with implant wear and corrosion.The patient experienced pain, clunking, popping sensations.A large pseudotumor was excised around the acetabular component.There was bone loss around acetabulum and femoral component.Cell count came back negative.The head won't come off and there was black corrosive material around it.After the taper adapter was removed, there was extensive black corrosive wear inside the adapter and on the trunnion.It took an hour to remove the head and taper adapter.A definitive root cause cannot 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 42-50MM TPR INSRT-6
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8815127
• MDR Text Key: 151840249
• Report Number: 0001825034-2019-03125
• 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
• Report Date: 10/03/2019

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: 07/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 139252
• Device Lot Number: 480650
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 09/26/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other