MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR 28X44MM; PROSTHESIS HIP

Catalog Number	11-165212
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Concomitant medical devices: part # 163663/ 28mm dia cocr mod hd / lot # 745660; part # unknown / unknown cup / lot # unknown.
Event or Problem Description
It was reported that during an initial hip procedure the metal shell was not able to assemble over the poly liner.A surgical delay of 30 minutes was noted in order to attain another liner.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6 visual inspection found the construct to be partially assembled with the head.The ring is bent, gouging into the liner and preventing one of the cutouts from fully engaging.However; it is unknown if the ring was bent before the liner being engaged with shell or after.The pressure being exerted on the head does not allow it to ambulate freely.The dimensional analysis of shell was conforming during manufacturing.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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: RINGLOC BI-POLAR 28X44MM
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11640462
• Report Number: 0001825034-2021-01031
• Device Sequence Number: 19580108
• Product Code: JDI
• UDI-Device Identifier: 00880304209640
• UDI-Public: (01)00880304209640(17)250907(10)105060
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K051569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2025
• Device Catalogue Number: 11-165212
• Device Lot Number: 105060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1