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

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Ossification (1428)

Event Type  Injury  

Event Description

It was reported that a retrospective study was performed at a single healthcare system.No intraoperative or postoperative implant-related complications were reported.It was reported that eight patients developed heterotopic ossification (three brooker class i, two brooker class ii, and three brooker class iii); however, no surgical intervention was required.

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Event description: the journal article clinical outcomes of conical hip prosthesis used in primary total hip arthroplasty reports on 8 patients, which developed heterotopic ossification (three brooker class i, two brooker class ii, and three brooker class iii); however, no surgical intervention was required.Review of received data: journal article: clinical outcomes of conical hip prosthesis used in primary total hip arthroplasty.Results thirty-one thas were performed in 26 patients using a wagner cone prosthesis stem.[.] another eight patients developed heterotopic ossification (three brooker class i, two brooker class ii, and three brooker class iii); however, no surgical intervention was required.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.Conclusion: the journal article clinical outcomes of conical hip prosthesis used in primary total hip arthroplasty reports on 8 patients, which developed heterotopic ossification (three brooker class i, two brooker class ii, and three brooker class iii); however, no surgical intervention was required.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: GENERIC WAGNER CONE PROSTHESIS
• 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: 13840652
• MDR Text Key: 287897825
• Report Number: 0009613350-2022-00165
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 05/16/2022
• 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
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1