MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH; PROTHESIS, HIP

Catalog Number	00625006525
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Aseptic loosening (4883)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 7 years post implantation of a total hip arthroplasty, the patient was revised due to aseptic mobilization for total hip prothesis.There were no contributing factors related to the reported event.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4) day 18 g2: foreign: country: italy.H10: cat# 00-8753-054-02 lot# 63337686 trilogy it multi 54 jj, cat# 00-8751-011-32 lot# 62658657 hxpe liner neut 54 jj x 32 , cat# 00625006525 lot# 63596936 bone screw self-tapping 6.5 mm dia.25 mm length , cat# 4845-0204 lot# gy424646 - a4d01 howmedica/stryker stem, cat# 6519-1-032 lot# 50423501 - howmedica/stryker head, cat# 6519-t-204 lot# 53977705 - howmedica/stryker adapter.Customer has indicated that the product will 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated.Visual examination of the provided pictures identified the explanted liner, shell, and screws.The shell had scratches and gouging to the outer rim and inner spherical surface, likely from explant.The screws had foreign debris to the surface.The liner was broken into pieces and worn from explant.No further evaluation can be made.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 are not compatible: the stryker head and stem.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: extensive osteolysis along the acetabular and femoral implants of the left hip arthroplasty with suspected implant loosening as noted.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.A definitive root cause cannot be identified.This complaint was confirmed based on radiographs.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;d9;g3;h2;h3;h6;h11.Product was returned and evaluated.Visual examination of the returned products identified that the shell was returned with bio debris in the inner spherical surface.Gouges, indentations, and deformation damage were also present.Damage was found to the taper wall, anti-rotation scallops, square pocket, and cluster holes.The rim face was gouged and scratched.Both screws show hex with bio debris, nicks, and gouges from use.Outer head diameter, head shape, and taper have damage from use and extraction.Damage included deformation, gouges, and scratches.One of the two screws was bent.No other damage was noted.Where measured, the devices were conformed to product specifications.A definitive root cause cannot be identified and remains unchanged.This complaint was confirmed based on radiographs.If any further information is found which would change or alter any conclusions or information, a supplemental report 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. 25 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: 21459460
• Report Number: 0002648920-2025-00052
• Device Sequence Number: 20797068
• Product Code: LPH
• UDI-Device Identifier: 00889024119819
• UDI-Public: (01)00889024119819(17)260731(10)63427732
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2026

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: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 00625006525
• Device Lot Number: 63427732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 04/14/2026
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 06/26/2025; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2016
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown