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

Model Number N/A

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source- foreign: japan.Kosei sakamotoa, goro motomuraa, satoshi hamaia, satoshi ikemuraa, masanori fujiia, shinya kawaharaa, yusuke ayabea, yasuharu nakashima (2022) short-term results of total hip arthroplasty using a tapered cone stem for patients with previous femoral osteotomy.Journal of orthopaedics, 30, 83-87.Https://doi.Org/10.1016/j.Jor.2022.02.021.The journal article: short-term results of total hip arthroplasty using a tapered cone stem for patients with previous femoral osteotomy, mentions that one patient experienced a superficial infection which was treated by wound irrigation.The article states: one hip developed a superficial infection that was treated by wound irrigation.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Device is used for treatment.Medical records were not provided.A definitive root cause cannot be determined.The reported event cannot be confirmed.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

It was reported that one patient experienced a superficial infection which was treated by wound irrigation.Attempts have been made and no further information has been provided.

Event Description

Uppon reassessment the review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.Given this information, this medwatch will be voided.

Manufacturer Narrative

(b)(4).Upon reassessment the review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.Given this information, this medwatch will be voided.

• Brand Name: UNKNOWN WAGNER CONE STEM GENERIC
• 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: 15101259
• MDR Text Key: 296569547
• Report Number: 0009613350-2022-00385
• Device Sequence Number: 1
• Product Code: LZO
• 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,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 07/26/2022
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 06/30/2023
• 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
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other