MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 130°, RIGHT, ø 10 MM, 21.5 CM; ZNN HIP LNTERNAL FIXATION SYSTEM

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: znn⿢, cmn lag screw, 㸠10.5 mm, 100 mm, including set screw item#:47248510010 lot #:3076664.Standard 3.0mm 㿠anti-rotation pin item#:47249003004 lot #65166295.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head item#:47248403550 lot #65167444.G2: foreign: france.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.
Event or Problem Description
It was reported that a patient had a revision surgery approximately one (1) year after implantation due to pain and pseudoarthrosis.The nail was removed without difficulty, and a total hip arthroplasty was performed without complications.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: d9, g3; h2; h3; h6.The reported znn cmn nail as well as the lag screw and set screw were returned to the post market surveillance team for examination.The nail has several scratches and polished surfaces in and around the holes used for lag screw and cortical screw placement, likely mainly occurring during implantation or revision surgery.Additionally, there are multiple scratches and damages within the proximal interface, used for insertion of the set screw and assembly with instruments for implantation and/or extraction of the nail.The lag screw shows multiple scratches and polished surfaces throughout the screw.A notch can be seen on one of the grooves of the lag screw, where the set screw likely was in contact with.The flute of the lag screw appears slightly deformed and also shows signs of damage in the form of scratches, likely due to either the implantation or extraction with the dedicated instrument.The set screw appears mainly inconspicuous.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.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: general anesthesia, posterolateral approach, revision due to pain and pseudoarthrosis, znn removed without difficulty, no significant findings dictated regarding implants, non-zb components implanted without complications radiographs were not sent at this time as records provide sufficient dictation of findings.Based on the available information, the reported event can be confirmed.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 event information at this time.

• Brand Name: CMN FEMORAL NAIL, CCD 130°, RIGHT, ø 10 MM, 21.5 CM
• Common Device Name: ZNN HIP LNTERNAL FIXATION SYSTEM
• 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: 19548445
• Report Number: 0009613350-2024-00237
• Device Sequence Number: 11964959
• Product Code: HSB
• UDI-Device Identifier: 00889024298910
• UDI-Public: (01)00889024298910(17)310621(10)3076099
• 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: 2021
• Device Explanted 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): 10/18/2024

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: 47249321210
• Device Lot Number: 3076099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 52 KG