MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN WAGNER CONE STEM; HIP PROSTHESIS

Model Number N/A

Device Problems Output Problem (3005); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 02/11/2022

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Even happening in (b)(6).Investigation of this incident is currently ongoing.A followup/ final report will be submitted when additional information becomes available.Reference: m.Shahin, v.Masse, e.Belzile et al.,.(2022) mid-term results of titanium conical wagner stem with challenging femoral anatomy: survivorship and unique bone remodeling.Orthopaedics & traumatology surgery & research (1877-0568) no.Of pages 9 https://doi.Org/10.1016/j.Otsr.2022.103242.

Event Description

It was reported in a journal article that a patient required an intervention due to supracondylar shortening osteotomy for sciatic neuropathy (persistent pain and paresthesia) secondary to overlengthening 3 months postoperatively.Limb sensory function was reported as recovered.Attempts have been made and no further information has been provided yet.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: event description: the journal article midterm results of titanium conical wagner stem with challenging femoral anatomy: survivorship and unique bone remodeling reports on one patient, which underwent a supracondylar shortening osteotomy for sciatic neuropathy (persistent pain and paresthesia) secondary to over lengthening 3 months postoperatively and limb sensory function was recovered.2.Review of received data: - journal article: midterm results of titanium conical wagner stem with challenging femoral anatomy: survivorship and unique bone remodeling adverse events (page 5): one hip (1/91) (1.1%) was reoperated by a supracondylar shortening osteotomy for sciatic neuropathy (persistent pain and paresthesia) secondary to over lengthening 3 months postoperatively and limb sensory function was recovered.- no medical data is available.- due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: - no product was returned.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check could not be performed due to missing product identification of the involved products.- dhr review: review of the device history records could not be performed due to missing reference and lot numbers.- a complaint history could not be performed due to missing reference and lot numbers.Conclusion the journal article midterm results of titanium conical wagner stem with challenging femoral anatomy: survivorship and unique bone remodeling reports on one patient, which underwent a supracondylar shortening osteotomy for sciatic neuropathy (persistent pain and paresthesia) secondary to over lengthening 3 months postoperatively and limb sensory function was recovered.The investigation did not identify a nonconformance or a complaint out of box (coob).Based on the journal article and the information provided, no detailed assessment of the reported event could be conducted.Therefore, a definite cause could not be found.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: UNKNOWN WAGNER CONE STEM
• 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: 14216722
• MDR Text Key: 290145576
• Report Number: 0009613350-2022-00255
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other