MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products ¿ associated products to be listed, if applicable: ball nose guide wire 100cm: item#: 281001100; lot#: 508380.Cmn femoral nail, ccd 130, right, 11.5 mm, 30 cm: item#: 47-2493-302-11; lot#: 3025294.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: item#: 47-2484-035-50; lot#: 65225644.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: item#: 47-2484-032-50; lot#: 65167613.Report source ¿ foreign ¿ 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.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00398.
Event or Problem Description
It was reported that the patient underwent an initial right hip arthroplasty and approximately six (6) weeks post-implantation started to experience pain.Implant fracture was discovered in post-op x-rays.Revision is not planned, the patient's condition will be continued to be monitored.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device are used for treatment.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: first review: x-ray: components in place, fracture not healed.No exact date of occurrence, proximately 6 weeks post op.Second review: good healing, no pain, ambulating with partial support.X-ray; no secondary displacement with nail in place.Third review: slight pain, normal finding.X-ray; fracture of nail.Options presented and patient does not want a revision, will continue to ambulate with support.Heel cup prescribed; patient refused.A definitive root cause cannot 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 available at the time of this report.

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 15138409
• Report Number: 0009613350-2022-00399
• Device Sequence Number: 12196599
• Product Code: HSB
• UDI-Device Identifier: 00889024298460
• UDI-Public: (01)00889024298460(17)260625(10)3075443
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N/A
• 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): 10/17/2022

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: Lay User/Patient
• Device Expiration Date: 06/25/2026
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-105-10
• Device Lot Number: 3075443
• 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: 06/17/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Female