MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING; PROSTHESIS, HIP

Catalog Number	00625006530
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the screw could not be assembled with the cup.Surgeon followed technique to insert cup and used the corresponding specified drill bit.After measuring length and selecting screw, the screw could not be completely screwed into the cup and appeared to be slightly slippery.Another screw was able to be used.There was a five minute delay.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign ¿ china.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d9; g3; h2; h3; h6.The following sections were corrected: h4.Visual examination of the returned product identified hex visually appears to be stripped.The head of the screw has scratch lines going around it from top to bottom of head.The lead thread has nick in it.No other damage was noted during visual evaluation.Measurements are within limits, hex dimensions are not being evaluated due to damaged state of hex.Review of the device history record identified no deviations or anomalies during manufacturing.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 information is available at the time of this report.

• Brand Name: BONE SCREW SELF-TAPPING
• 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: 22043411
• Report Number: 0002648920-2025-00138
• Device Sequence Number: 8898791
• Product Code: LPH
• UDI-Device Identifier: 00889024119826
• UDI-Public: (01)00889024119826(17)340514(10)66711835
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00625006530
• Device Lot Number: 66711835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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
• Patient Sex: Unknown