MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH; PROSTHESIS, HIP

Catalog Number	00625006540
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 110010267 lot# 65564359 g7 osseoti multihole 58mm g.Cat# 20123607 lot# 67133411 36mm i.D.Size g high wall liner.Cat# 51-104150 lot# j7888034 tprlc 133 t1 pps ho 15x150mm.Cat# 650-0663 lot# 3134699 delta ceramic fem hd 36/+6mm.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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 the patient underwent an initial hip procedure.Subsequently, the patient is being considered for a second revision on an unknown date due to insufficient fixation of the cup.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; g3; h2; h3; h4; h6.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.Medical records were not provided.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 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. 40 MM LENGTH
• Common Device Name: PROSTHESIS, 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: 22991046
• Report Number: 0002648920-2025-00240
• Device Sequence Number: 9089760
• Product Code: LPH
• UDI-Device Identifier: 00889024119840
• UDI-Public: (01)00889024119840(17)340206(10)66540078
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K93476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/30/2025

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: Lay User/Patient
• Device Catalogue Number: 00625006540
• Device Lot Number: 66540078
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male