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

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 110030158 dm univ prov brg 28 x 44mm lot# zb170502.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr's submitted for this complaint: 0001825034 - 2018 - 02225.

Event Description

It was reported that during a hip arthroplasty, the surgeon was unable to dislocate the hip after completing trialing.After multiple attempts, the surgeon decided to cut the trials out with a saw.There was a 45 minute delay in procedure as a result.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Product was not returned to zimmer biomet for evaluation.This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of associated device (associated mdr) which indicated through visual inspection wear marks, cutting marks and few pieces were missing from the returned instrument.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.

• Brand Name: UNKNOWN LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7634432
• MDR Text Key: 112200363
• Report Number: 0001825034-2018-03903
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention