MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP

Device Problem Corroded (1131)

Patient Problem Hip Fracture (2349)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown, unknown cup, lot #: unknown.Item #: unknown, unknown head, lot #: unknown.Item #: unknown, unknown liner, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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: 0001825034-2019-03105, 0001825034-2019-03106.

Event Description

It was reported that a patient had an initial right total hip arthroplasty.Subsequently, approximately ten years post implantation, the patient was diagnosed with osteolysis, elevated metal ions, and a lesser trochanteric fracture.Patient underwent a revision surgery and during the procedure a significant amount of metallosis with trunnionosis was noted.Additional information was requested however none was available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records which indicated: diagnosis of lesser trochanteric fracture which was atraumatic.X-rays review indicated significant osteolysis.Significant metallosis noted as well as osteolysis within the proximal femur.Well-fixed femoral stem.Evidence of trunnionosis but without damage to the trunnion.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.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.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8807135
• MDR Text Key: 151583856
• Report Number: 0001825034-2019-03108
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: 07/23/2019
• Supplement Dates FDA Received: 07/25/2019
• 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
• Patient Age: 67 YR