MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH MULTI HOLES 58 MM; PROSTHESIS, HIP

Model Number	6202-58-20
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
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.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: bone screw self-tapping 6.5 mm dia.15 mm length: catalog#00625006515, lot#63397013; bone screw self-tapping 6.5 mm dia.35 mm length: catalog#00625006535, lot#j7241829.Report source: foreign: germany.Two screws have been reported for this event.At the time of this report, it is unknown which screw is implicated in the adverse event.Both have been reported under the following associated reports: 0002648920-2022-00226; 0001822565-2022-03147.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.
Additional Manufacturer Narrative
Visual and dimensional evaluations could not be performed as no product was returned nor were pictures provided.The product remains implanted.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty with screw fixation of the acetabular cup.The screw appears to have slipped through the screw hole and no longer secures the acetabular cup.Root cause was unable to be determined.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 at time of this report.

• Brand Name: SHELL POROUS WITH MULTI HOLES 58 MM
• 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: 15754526
• Report Number: 0001822565-2022-03167
• Device Sequence Number: 2918514
• Product Code: LPH
• UDI-Device Identifier: 00889024118959
• UDI-Public: (01)00889024118959(17)320125(10)64787277
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093561
• 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): 12/20/2022

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 Model Number: 6202-58-20
• Device Catalogue Number: 00620205820
• Device Lot Number: 64787277
• 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: 12/14/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2022
• 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 H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 80 KG