MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BI-METRIC/X POR NC LAT 17X165; PROSTHESIS, HIP

Model Number N/A

Device Problems Separation Failure (2547); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tissue Damage (2104)

Event Date 10/08/2018

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: 157454, m2a-magnum mod hd sz 54mm, lot: 592260, part: 139266, m2a-magnum 52-60mm tpr insrt-3, lot: 799460, part: us157860, m2a-magnum pf cup 60odx54id, lot: 086490, part: x11-180317, bi-metric/x por nc lat 17x165, lot: 219470.Multiple mdr reports were filed for this event, please see associated reports: head: 0001825034-2019-04521, taper: 0001825034-2019-04529, cup: 0001825034-2019-04528.

Event Description

It was reported that the patient underwent a primary right tha and subsequently experienced pain and a pre-revision work up revealed osteolysis.During the revision surgery, the surgeon reported debris, altr, along with osteolysis.While attempting to remove head/taper from stem, it was reported as cold-welded to stem, and required trochanter osteoectomy to remove stem.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records noting pain, osteolysis and large volume of mixed fluid with debris.Cup was removed and large osteolytic areas filled with cancellous bone chips was noted.Upon attempting to remove the head taper from the stem, it was found to be cold-welded requiring a trochanteric osteotomy in order to remove the stem.Dhr was reviewed and no discrepancies were found.Root cause is 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.

• Brand Name: BI-METRIC/X POR NC LAT 17X165
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9163454
• MDR Text Key: 161804662
• Report Number: 0001825034-2019-04527
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K030055
• 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: 02/05/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: N/A
• Device Catalogue Number: X11-180317
• Device Lot Number: 219470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/05/2020
• 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