MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X50 SELF-TAP; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a total hip arthroplasty.The patient was non-compliant (due to the patient not following restrictions at rehab) and the cup, augment block, and screws loosened.Therefore, the patient was revised with a bigger cup, bigger augment, and screws approximately 1-2 months later.Subsequently, the patient was non-compliant again, therefore will be revised again in the near future with a custom trifflange.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant products: cat# 110010267 g7 osseoti multihole 58mm g lot#7084562; cat# 802804004 zb type 1 ceramic hd 40mm x +6 lot# 3045483; cat# 51-101070 tprlc 133 fp type1 pps ho 7.0 lot#6656562; cat# 00625006535 bone scr 6.5x35 self-tap lot# j7105903; cat# 00625006540 bone scr 6.5x40 self-tap lot# j7031156; cat# 00625006540 bone scr 6.5x40 self-tap lot# 65094425; cat# 00625006540 bone scr 6.5x40 self-tap lot# j7130462; cat# 00625006550 bone scr 6.5x50 self-tap lot# j6909648; cat# 00625006550 bone scr 6.5x50 self-tap lot# j6909648; cat# 00489405020 trabecular metalâ¿¢ acetabular revision system acetabular augment lot# 64634283.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 00261, 0001822565 - 2022 - 00262, 0002648920 - 2022 - 00021, 0001822565 - 2022 - 00263, 0001822565 - 2022 - 00264.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: d4; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.A review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to the patient being non compliant to post op care as reported by the surgeon.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: BONE SCR 6.5X50 SELF-TAP
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13415838
• Report Number: 0001822565-2022-00265
• Device Sequence Number: 3886724
• Product Code: LPH
• UDI-Device Identifier: 00889024119857
• UDI-Public: (01)00889024119857(17)301204(10)J6909648
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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 Model Number: N/A
• Device Catalogue Number: 00625006550
• Device Lot Number: J6909648
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Female