MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN FITMORE CUP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Trend analysis: no trend analysis could be performed as no item/lot numbers are available.Device history records (dhr): the dhr check could not be performed as the lot number was not available.Event description: event summary: it was reported in the received journal article that 1111 patients underwent revision surgery due to unknown reason.Review of received data no medical data such as x-rays, surgical notes or any other case-relevant documents received.However, the used zb product was combined with a competitor product (conus stem) which is considered off-label use.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Conclusion: the source of this complaint is a journal article based on registry data: neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implant(s) were received; therefore the condition of the component(s) is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.In conclusion, due to significant lack of information, it is impossible to perform a detailed analysis of the reported event.However, the available product information indicate that the zb product was combined with a competitor product which is considered off-label use.Due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.Zimmer (b)(4) considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

A journal article entitled "arthroplasty registries around the world: valuable sources of hip implant revision risk data" was received, where the authors evaluated sources of hip implant revision risk data.The purpose of this paper was to briefly describe arthroplasty registry concepts, international registries around the world, us registries, and provide a parsimonious summary of total hip arthroplasty (tha) implant revision risk reports across registries.Revision risk data for conventional stem/cup combinations reported by various registries were summarized in the journal article.These registries were selected because they presented 10-year data on revision risk by stem/cup combination.For the present case, it was reported in the received journal article that 1111 patients were implanted with a fitmore cup and underwent revision surgery due to unknown reason.The data were pulled out from ripo registro dell`implantologia protesica ortopedica, italy joint registry - 10 year data.Source: "arthroplasty registries around the world: valuable sources of hip implant revision risk data" , hughes, e.Et al, orthopaedic health policy (2017).

• Brand Name: UNKNOWN FITMORE CUP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 7062587
• MDR Text Key: 93033984
• Report Number: 0009613350-2017-01667
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2017
• 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; Required Intervention