MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. SIZE E NEUTRAL LINER; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 574202060 femoral stem cementless collared high offset 12/14 taper size 6 3137541.010000663 g7 pps ltd acet shell 52e 7450970.00625006525 bone screw self-tapping 6.5 mm dia.25 mm length j7458211.30103605 36mm i.D.Size e neutral liner 65875351.00877503601 biolox⮠delta, ceramic femoral head, s, 㸠36/-3.5, taper 12/14 3144443.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during the procedure, the surgeon had a hard time dislocating the trial as the patient¿s leg lengths were too long.The surgeon was unable to dislocate the patient for an anterior approach and purposely shattered the trial head breaking the head into pieces.A broken piece remained in the patient¿s body.The patient dislocated due to the broken piece and needed additional surgery.The patient was revised one month post operation.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: g3; h2; h3; h6 visual examination of the provided picture in the linked complaint identified the explanted fragment that was previously retained and is covered in bio debris.No pictures were provided of the liner.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The root cause of the reported issue is attributed to the retained fragment from the broken trial, and thus no problem is found with the liner and subsequent dislocation.The dislocation caused from the retained piece is captured in the linked complaint.This complaint was confirmed based on the provided picture of the explanted trial fragment.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: 36MM I.D. SIZE E NEUTRAL LINER
• Common Device Name: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17457764
• Report Number: 0001822565-2023-02084
• Device Sequence Number: 19507597
• Product Code: LPH
• UDI-Device Identifier: 00889024519909
• UDI-Public: (01)00889024519909(17)280405(10)65875351
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 30103605
• Device Lot Number: 65875351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female