MAUDE Adverse Event Report: ZIMMER GMBH ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 95 MM, INCLUDING SET SCREW; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision was planned approximately 1 year post-implantation for removal of the osteosynthesis material from the femur in a patient with a long trochanteric nail, following pain.However, it was noted that the procedure could not be completed due to malfunction during the operation (see section h11).Attempts have been made and additional information on the reported event has not yet been provided.
Additional Manufacturer Narrative
(b)(4).B5: the malfunction that occurred during operation and caused the procedure to be aborted has been captured and will be reported under zimmer biomet complaint number (b)(4).D10: unknow item #, unknow znn long trochanteric nail, lot # unknown.G2: report source france.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4): this follow-up report is being submitted to relay additional information.D10: item # 47249338111, cmn femoral nail, ccd 125â°, left, 㸠11.5 mm, 38 cm, lot # 3134388.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.Based on the available information received, the reported event can be confirmed.It cannot be determined whether the revision surgery has been performed to date.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information at this time.

• Brand Name: ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 95 MM, INCLUDING SET SCREW
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19701913
• Report Number: 0009613350-2024-00283
• Device Sequence Number: 3641321
• Product Code: HSB
• UDI-Device Identifier: 00889024298446
• UDI-Public: (01)00889024298446(17)271220(10)3140285
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 11/06/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47248509510
• Device Lot Number: 3140285
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 10/22/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/12/2024; 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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 H11 NARRATIVE.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 64 KG