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

Model Number N/A

Device Problem Peeled/Delaminated (1454)

Patient Problems Pain (1994); Osteolysis (2377); Osteopenia/ Osteoporosis (2651)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: m2a-magnum mod hd sz 52mm, pn 157452, ln 483800, m2a-magnum 52-60mm tpr ins std, pn 139268, ln 650390, item# us157858 m2a-magnum pf cup 58odx52id lot# 768650.Customer has indicated that the product will not be returned to zimmer biomet for investigation due to hospital policy.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 -05350.

Event Description

It was reported that the patient underwent a revision of right total hip arthroplasty approximately 10 years post initial implantation due to pain.Upon explantation of the cup delamination of the pps coating was discovered.Xray review indicated radiolucency, osteolysis, and osteopenia.All components were revised.

Event Description

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

Manufacturer Narrative

The product was evaluated through radiographic inspection and the reported event was confirmed through review of medical records.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not be determined with the information 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.

• 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: 9490936
• MDR Text Key: 172194383
• Report Number: 0001825034-2019-05645
• 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: 03/31/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 03/31/2020
• 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