MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER ELEVATED RIM 32 MM I.D. SIZE HH FOR USE WITH 50 MM O.D. SIZE HH SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional 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.Device available for evaluation: part: 00875305001, lot: 64670624.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00566.
Event or Problem Description
It was reported that the cup and liner would not mate.Attempts have been made and no further information has been provided.
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.Visual review of the liner elevated rim 32 mm i.D.Size hh for use with 50 mm o.D.Size hh shell [item 00875200932 lot 64671659] lot identification is confirmed.Elevated rim, anti rotation scallops, outer rim face, and spherical bottom show nicks and gouges.(12) anti rotation scallops were confirmed and deformation damage of scallops are noted.Spherical bottom indentation and gouge damage in a semi circular shape was noted.Review of the device history records identified no deviations or anomalies during manufacturing.  a definitive root cause could not be determined.A summary of the investigation has been sent to the complainant.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: LINER ELEVATED RIM 32 MM I.D. SIZE HH FOR USE WITH 50 MM O.D. SIZE HH SHELL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11411880
• Report Number: 0001822565-2021-00558
• Device Sequence Number: 3764900
• Product Code: JDI
• UDI-Device Identifier: 00889024149694
• UDI-Public: (01)00889024149694(17)200702(10)64671659
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 00875200932
• Device Lot Number: 64671659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1