MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 44 MM O.D.; HIP PROSTHESIS

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Code Available (3191)

Event Date 02/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.(b)(4).Report source: (b)(6).

Event Description

It was reported that the ringloc on the cup was defective and prevented the liner from seating into the cup.The surgery was completed with another cup.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned shell showed one of two tabs of the locking ring were seized in the locking ring groove.Device history record (dhr) was reviewed and no discrepancies were found.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: SHELL 44 MM O.D.
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 8375608
• MDR Text Key: 137314134
• Report Number: 0002648920-2019-00146
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K833991
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• 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: 00500104400
• Device Lot Number: 64193631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention