MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; TRAUMA IMPLANT

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had an initial surgery approximately 2 years ago.Subsequently, about 8 months later they had a revision due to exit of the cervical screw from the joint and sinking into the acetabulum.During the revision noted the acetabular roof was fractured.All components were exchanged with competitor product.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).G2: france d10 - medical product: catalog #: 47249321111, cmn femoral nail, ccd 125â°, left, ã, lot # 3084464 catalog #: 47248509010, znnâ¿¢, cmn lag screw, ã screw, lot # 3015087 catalog #: 47249003004, standard 3.0mm ã¿ anti-rotation pin, lot # 65206661 h3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).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.
Additional Manufacturer Narrative
(b)(4).Updated: a1, a3, b4, b5, d2, g3, h1, h2, h3, h4, h6, h11 reported event was unable to be confirmed as the reported event was not related to this device as the migration and bone fracture is related to the lag screw and nail on the linked complaint.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: scanning of a zimmer left hip nail with exit of the cervical screw from the joint and sinking into the acetabulum.General anesthesia and moore posterolateral approach used.Nail excised easily along with the femoral head.Acetabulum roof found fractured.Competitor product placed without complications.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: three views of the left hip demonstrate a left femoral intramedullary rod with one distal interlocking screw, and a malposition of the gamma nail with superior position of the distal tip which appears to protrude into the superior femoral acetabular joint.Vascular calcifications.Surgical skin staples.Sizing is appropriate.Question mild osteopenia.No other anatomical or implant failures that would lead to revision.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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 available at the time of this report.

• Brand Name: 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD
• Common Device Name: TRAUMA IMPLANT
• 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: 19392948
• Report Number: 0001822565-2024-01734
• Device Sequence Number: 15391885
• Product Code: HSB
• UDI-Device Identifier: 00889024094017
• UDI-Public: (01)00889024094017(17)310922(10)65225702
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2024

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: N/A
• Device Catalogue Number: 47248403550
• Device Lot Number: 65225702
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 05/13/2024; 11/06/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/10/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 62 KG