MAUDE Adverse Event Report: ZIMMER GMBH AVENIR MULLER STEM 5 STANDARD

Model Number N/A

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Medical products and therapy date detail of product: item number unknown, item name fitmore shell with screw cone,s lot number unknown.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.Zimmer biomet¿s reference number of this file is (b)(4).Complaint linked to (b)(4).Item and lot number unknown.

Event Description

The tga has sent a deficiency based on the recent aoa joint registry because three patients underwent revision surgery due to infection.

Manufacturer Narrative

Additional information which was received on nov 13, 2019.D11- medical product: fitmore shl w scr cones 56/kk; item#0100024556; lot#2866354; cocr head 32/+4 lg 12/14; item#14320720; lot#2863536; dural alpha insert neutr kk/32; item#0100013411; lot#2889364; countersunk cancell scr 6.5/19; item#421920; lot#unknown; countersunk cancell scr 6.5/30; item#421930; lot#unknown; cancl bone scw ti 6.5mmx2; item#430107020; lot#unknown; cancl bone scw ti 6.5mmx3; item#430107030; lot#unknown.Therapy date: unknown.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Should additional information become available and/or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on an unknown side and underwent revision potentially due to one of the following events: dislocation/infection/loosening/fracture/pain.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: trend analysis can not be conducted as the specific event is not available.Thus, no similarities to investigated events can be compared.Event description: it was reported by the therapeutic goods administration (tga) that the australian orthopaedic association national joint replacement registry (aoanjrr) has registered a higher than expected revision rate for a combination of avenir stem / fitmore cup used for total hip arthroplasty.The reason for revision surgery is unknown, but could however be one of the following: dislocation, infection, loosening, fracture and pain.Review of received data: data extract from the aoanjrr received for the higher than expected revision rate for a combination of avenir stem / fitmore cup used for total hip arthroplasty providing data such as: average duration of implantation, implant catalog ranges, reason for revision surgeries and years of which the products were revised.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Raw material certificate reviewed on: 15-jan-2020.The review showed that the materials were manufactured according to specification.Sterilization certificate reviewed on: 15-jan-2020.The review showed that the devices were sterilized according to specification.Conclusion: it was reported by the therapeutic goods administration (tga) that the australian orthopaedic association national joint replacement registry (aoanjrr) has registered a higher than expected revision rate for a combination of avenir stem / fitmore cup used for total hip arthroplasty.The reason for revision surgery is unknown, but could however be one of the following: dislocation, infection, loosening, fracture and pain.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The raw material certificate confirm the correct specifications of the raw material composition.The sterilization certificate confirm the correct sterilization according to specification.The countersunk cancellous screws are distributed as non-sterile products and are sterilized internally at the hospital according to their process.Neither x-rays, operative notes, office visit notes, nor devices or photos of the revised implants were received; therefore the condition of the components 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.It is only known that there was a revision surgery either due to one of the following events: dislocation, infection, loosening, fracture or pain.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.Issue evaluation has been initiated on 24.10.2019 as per management request to further address this outlier report.Investigation for warsaw products captured under (b)(4).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

Please refer to report 0009613350-2019-00662.

• Brand Name: AVENIR MULLER STEM 5 STANDARD
• Type of Device: AVENIR MULLER STEM 5 STANDARD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9294297
• MDR Text Key: 165545042
• Report Number: 0009613350-2019-00662
• Device Sequence Number: 1
• Product Code: KWY
• 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,s
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.005
• Device Lot Number: 2853014, 2889871
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: REFER TO H10; SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention