MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL WITH CLUSTER HOLES POROUS 50 MM O.D. SIZE HH FOR USE WITH HH LINERS; 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.Concomitant medical products: part: 00875200932, lot: 64671659.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00558.
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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual review of the shell with cluster holes porous 50 mm o.D.Size hh for use with hh liners [item 00875305001, lot 64670624] lot identification is confirmed.Fiber metal spherical surface shows no damage to the fiber metal.Inner spherical surface shows (12) anti rotation cut outs.Nicks and scratches were noted to the inner spherical surface and rim face.No other damage 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: SHELL WITH CLUSTER HOLES POROUS 50 MM O.D. SIZE HH FOR USE WITH HH LINERS
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11411859
• Report Number: 0001822565-2021-00566
• Device Sequence Number: 17084934
• Product Code: JDI
• UDI-Device Identifier: 00889024150157
• UDI-Public: (01)00889024150157(17)200810(10)64670624
• 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 Model Number: N/A
• Device Catalogue Number: 00875305001
• Device Lot Number: 64670624
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10