MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCREW SELF-TAPPING 6.5 MM DIA.25MM; PROSTHESIS, HIP

Catalog Number	00625006525
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Joint Dislocation (2374); Aseptic loosening (4883)
Date of Event	08/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10: shell porous with multi holes 58 mm, item: 00620205820, lot: 63257036.Bone screw self-tapping 6.5 mm dia.20 mm length, item: 00625006520, lot: 63622282.Bone screw self-tapping 6.5 mm dia.25 mm length, item: 00625006525, lot: 63696898.Bone screw self-tapping 6.5 mm dia.30 mm length, item: 00625006530, lot: 63855074.Bone screw self-tapping 6.5 mm dia.50 mm length, item: 00625006550, lot: 62400530.Liner standard 3.5 mm offset 36 mm i.D.For use with 58 mm o.D.Shell, item: 00630505836, lot: 63851012.G2: foreign ¿ australia.The customer indicated that the product location is unknown; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a right hip revision approximately 6-months post implantation due to dislocation.During the revision the acetabular component was found to be loose.The stem was retained and all other implants were revised.It was confirmed that no further information could be provided.
Event or Problem Description
It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a2; d4; g3; h2; h3; h4; h6; h10.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 related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient had a right hip dislocation and had a revision in 2018.Findings during the surgery notes abductors were deficient.Femoral head and liner were removed, and acetabulum was found loose and removed.No complication noted.A definitive root cause cannot be determined.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 trends.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA.25MM
• Common Device Name: PROSTHESIS, 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: 24011901
• Report Number: 0001822565-2026-00113
• Device Sequence Number: 18477386
• Product Code: LPH
• UDI-Device Identifier: 00889024119819
• UDI-Public: (01)00889024119819(17)270831(10)63776543
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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 Catalogue Number: 00625006525
• Device Lot Number: 63776543
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2017
• 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 H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female