MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 15 MM LENGTH; PROSTHESIS, HIP

Model Number	6250-65-15
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: shell porous with multi holes 58 mm: catalog#00620205820, lot#64787277; bone screw self-tapping 6.5 mm dia.35 mm length: catalog#00625006535, lot#j7241829.Foreign: germany.Two (2) screws have been reported for this event.At the time of this report, it is unknown which screw is implicated in the adverse event.The additional screw has been reported under 0001822565-2022-03147.Please also see associated report: 0001822565-2022-03167.The product will not be returned for evaluation as it remains implanted.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow up mdr will be submitted.
Event or Problem Description
It was reported a patient underwent a total hip procedure.During the procedure, while securing the shell, a screw slipped entirely through the screw hole.There was a delay of fifteen minutes while the surgeon attempted to remove the screw, but was unable.The screw remains in the patient.Due diligence is in process for this complaint; to date no additional information has been provided.
Event or Problem Description
Upon receipt of additional information, this device was determined to be not reportable.The screw referenced in this report did not cause or contribute to the reported adverse event.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
This follow up report is being submitted to relay additional information.Upon receipt of additional information, this device was determined to be not reportable.The screw referenced in this report did not cause or contribute to the reported adverse event of foreign body retention.The initial report was forwarded in error and should be voided.The device that was retained by the patient has been reported under mfr 0001822565-2022-03147.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 15 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: 15754549
• Report Number: 0002648920-2022-00226
• Device Sequence Number: 19562757
• Product Code: LPH
• UDI-Device Identifier: 00889024119796
• UDI-Public: (01)00889024119796(17)260630(10)63397013
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/16/2022

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: 06/30/2026
• Device Model Number: 6250-65-15
• Device Catalogue Number: 00625006515
• Device Lot Number: 63397013
• 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: 10/14/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2016
• 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: Other
• Patient Sex: Female
• Patient Weight: 80 KG