MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BEARING 28 MM I.D. 38 MM O.D. SIZE C; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant products: part: 00625006530, lot: j6871104, bone scr 6.5x30 self-tap; part: 00625006530, lot: j6871104, bone scr 6.5x30 self-tap; part: 00625006535, lot: 64894201, bone scr 6.5x35 self-tap; part: 00625006525, lot: j6846725, bone scr 6.5x25 self-tap; part: 31-323230, lot: 659390, 3.2mmx30mm rnglc+ acet drl bit; part: 00700006420, lot: 64331687, trabecular metalâ¿¢ acetabular revision shell; part: 00712506254, lot: 3004361, acetabular revision system - cage, right long flange use with 62/64 mm shells; part: 00625006530, lot: 64945767, bone scr 6.5x30 self-tap; part: 00625006530, lot: j6871102, bone scr 6.5x30 self-tap; part: 00625006530, lot: j6871102, bone scr 6.5x30 self-tap; part: 00625006515, lot: j6829153, bone scr 6.5x15 self-tap; part: 00625006535, lot: j6719372, bone scr 6.5x35 self-tap; part: 31-323240, lot: 233730, 3.2mmx40mm rnglc+ acet drl bit; part: 00625006530, lot: j6964165, bone scr 6.5x30 self-tap; part: 00625006530, lot: 64945771, bone scr 6.5x30 self-tap; part: 163651, lot: j6858532, 22.2mm dia cocr mod hd std nk; part: 650-1055, lot: 3030897, cer bioloxd option hd 28mm.
Event or Problem Description
It was reported patient underwent a revision procedure approximately four months and 20 days post-implantation due to a worn and fractured bearing.Attempts to obtain additional information have been made; however, no more is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Visual examination of the provided pictures identified significant wear on the bearing and a fracture.Products covered in bio-debris.An obsoleted shell was identified in the provided pictures.No further evaluation can be made from the pictures provided.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility and it was determined that the following implants/instruments are not compatible: the obsoleted m2a-38 cup shown in the provided pictures.It is obsoleted and therefore not compatible with the bearing used in the procedure.The root cause of the reported issue is attributed to off label usage, as the bearing and shell are not compatible.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: BEARING 28 MM I.D. 38 MM O.D. SIZE C
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12197753
• Report Number: 0001822565-2021-01993
• Device Sequence Number: 19834117
• Product Code: KWY
• UDI-Device Identifier: 00889024572676
• UDI-Public: (01)00889024572676(17)250228(10)64689614
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 110031009
• Device Lot Number: 64689614
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 10/07/2021
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention