MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 48 MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Code Available (3191)

Event Date 05/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001822565 - 2019 - 02869.

Event Description

It was reported that during the course of total hip arthroplasty, the liner would not lock into the shell.It was noted the shell was removed and another shell was used to finish surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned shell identified that the locking ring was tight, deformed and not fully seated in the groove.Removal of the locking ring identified foreign debris stuck within the groove.The debris was removed and analyzed and found to be consistent with a vinyl acrylic material (butyl acrylate).The device history records were reviewed and no discrepancies relevant to the reported event were identified.Although it can be confirmed that the debris in the locking ring's groove prevented the locking ring from moving as intended, a definitive root cause cannot be determined for how the debris became lodged in the groove.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: SHELL POROUS WITH CLUSTER HOLES 48 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8770048
• MDR Text Key: 150363712
• Report Number: 0001822565-2019-02874
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K093561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

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 Model Number: N/A
• Device Catalogue Number: 00620204822
• Device Lot Number: 64005068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN HEAD; UNKNOWN STEM; ZIMMER LINER, CAT#00631004832, LOT#64291666
• Patient Outcome(s): Other
• Patient Weight: 75