MAUDE Adverse Event Report: ZIMMER GMBH AVENIR MLLER STEM 1 STANDARD; AVENIR MULLER STEM

Model Number N/A

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Hip Fracture (2349); No Information (3190)

Event Date 09/03/2019

Event Type  Injury  

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.Attempts to obtain additional information have been made; however, no more is available.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.(b)(4).

Event Description

It was reported that during implantation something fractured (incident report does not specify if stem or patient's bone).Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

Investigation results were made available.Dhr review: ref#: (b)(4) lot#: 2970810.Yield: 40.Delivered: 40.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: functional : patient bone fractured event description: it was reported that during implantation of an avenir mueller stem, there was an intraoperative fracture of the femur leading to a surgical delay of about 30 minutes.The fracture required fixation.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis as the product remained implanted.Review of product documentation: this device is intended for treatment.Inspection performed according to dhr: 100% of the manufactured devices (40 from 40) were measured using the cmm-measuring programm.All measured characteristics and were found be to according to specifications.Conclusion summary: it was reported that during implantation of an avenir mueller stem, there was an intraoperative bone fracture of the femur which required fixation.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The investigation results did not identify a non-conformance or a complaint out of box (coob).As no x-rays have been received, the correct choice of implant size for the patient cannot be assessed.No operative notes were received; therefore it remains unknown whether the correct implantation steps have been performed.Moreover, patient factors that may contributed to the reported event such as bone quality are unknown.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.Therefore, an exact root cause cannot be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation results are now available.

Manufacturer Narrative

Additional information was received.The lot number was received for the device, the device history records were reviewed and found to be conforming.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).

Event Description

It was now reported that the stem did not break.The stem was implanted and there was a fracture of the femur.There was a delay of about 30 minutes to fix the fracture.

• Brand Name: AVENIR MLLER STEM 1 STANDARD
• Type of Device: AVENIR MULLER STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9074327
• MDR Text Key: 161928765
• Report Number: 0009613350-2019-00563
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024479456
• UDI-Public: 00889024479456
• Combination Product (y/n): N
• PMA/PMN Number: K123392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2019

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: 01.06010.001
• Device Lot Number: 2970810
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 09/18/2019; 11/19/2019
• Supplement Dates FDA Received: 10/15/2019; 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 52