MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 47 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problems Activation, Positioning or Separation Problem (2906); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign country: (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: 0002648920 - 2020 - 00537.

Event Description

It was reported that during an initial surgery, the c-ring in bipolar shell was locked with shell and it would not assemble with polyethylene liner, which led to a 20 minute delay to change into new implant.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

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.Visual review of the device as returned shows lock ring tab was not centered in the tab window.One tab was stuck in shell groove.Nicks, gouges, and deformation were noted to the lock ring.Lock ring was removed from the shell.Shell lock groove shows nicks and scratches.No other damage was noted to the shell.Lock ring was reinserted into the shell groove with tabs in shell tab window.The ring was able to move freely as intended within the lock ring groove.Review of the device history record for the shell identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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: SHELL 47 MM O.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11067173
• MDR Text Key: 223602685
• Report Number: 0002648920-2020-00536
• 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,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00500104700
• Device Lot Number: 62779209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 12/30/2020; 05/04/2021
• Supplement Dates FDA Received: 01/20/2021; 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN LINER
• Patient Age: 75 YR