MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 00489405810 lot# 63392067 trabecular metalâ acetabular revision system acetabular augment cat# 00662406540; lot# 64645209; bone screw selftapping 40mm length 6.5mm dia.Cat# 00-6624-065-50; lot# 63704590; bone scr 6.5x50 self-tap.Cat# 11-300814; lot# 774180; arcos 14x150mm spl tpr dist.Cat# 11-300818; lot# 147420; arcos 18x150mm spl tpr dist.Cat# 010000903; lot# 3743858; g7 10 deg e1 liner 40mm f.Cat# 11-301331; lot# 138850; arcos con sz a hi 70mm.Cat# 650-1058; lot# 2993268; cer bioloxd optionhd40mm.Cat# 650-1067; lot# 3031106; cer option type 1 tpr sleve+3.Cat# 00700005620; lot# 64564812; trabecular metal revision shell 56mm.Product remains implanted 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.Multiple mdr reports were filed for this event, please see associated report: 0001822565-2024-02532.
Event or Problem Description
It was reported that approximately 4 years post implantation of a right total hip arthroplasty, the patient is experiencing pain and a loose cup.Subsequently, the patient is being considered for a revision on an unknown date.No additional information was available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility, and it was determined that the following implants are not compatible: the 00625006550 screw with the tmars cup, and the augment, and the g7 liner with the tmars cup.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.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 is available at the time of this report.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH
• Common Device Name: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19906400
• Report Number: 0002648920-2024-00245
• Device Sequence Number: 18325821
• Product Code: LPH
• UDI-Device Identifier: 00889024119857
• UDI-Public: (01)00889024119857(17)290930(10)64561604
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: 64561604
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown