MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH Z NAIL CMF 10MMX21.5CM 125 R; HIP PROSTHESIS

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: z nail cmf 10.5 x 80 lag scr item# 47-2499-080-10 lot# 3070480, z nail cmf nail cap 0mm item# 47-2500-002-00 lot# 3059715, 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head item# 47-2484-027-50 lot# 65267002.Report source¿ foreign ¿ japan.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 report: 0009613350 - 2022 - 00498.

Event Description

It was reported that approximately two (2) months after the initial surgery, x-rays confirmed the lag screw was sliding to outer the side.Revision surgery is not planned, the patient's condition will continue to be monitored.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.As no product was returned, visual and dimensional evaluations could not be performed.Devices are used for treatment.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.Based on the available information it is not possible to determine the root cause for this issue.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 Description

No further event information available at the time of this report.

• Brand Name: Z NAIL CMF 10MMX21.5CM 125 R
• Type of Device: 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: 15485357
• MDR Text Key: 300580974
• Report Number: 0009613350-2022-00499
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024586031
• UDI-Public: (01)00889024586031(17)310511(10)3071179
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2498-210-10
• Device Lot Number: 3071179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose