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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	11/23/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products: countersunk cancel scr 6.5/25 part#42.19.25; lot#unknown, countersunk cancel scr 6.5/19 part#42.19.20; lot#unknown, cocr head 32/0 med 12/14 part#14.32.06-20, lot#2804223, dural alpha insert neutr hh/32 part#01.00013.408, lot#2799256, fitmore shl w scr cones 50/hh; part#0100024550; lot#2793934.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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 or Problem Description
Patient was implanted on an unknown side and is being monitored potentially due to one of these events : dislocation, infection, fracture, loosening or pain.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.A part specific investigation can not be conducted as the specific event is not available.Thus, no similarities to investigated events can be compared.Event summary: 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 or 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.Devices 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.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 summary: 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 explanted 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.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).The following reports are associated with this event: 0009613350-2019-00663, 0009613350-2019-00786, 0009613350-2019-00772.
Event or Problem Description
No change to previously reported event.

• Brand Name: AVENIR MULLER STEM 5 STANDARD
• Common Device Name: AVENIR MULLER STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9422116
• Report Number: 0009613350-2019-00774
• Device Sequence Number: 2491197
• Product Code: LZO
• UDI-Device Identifier: 00889024479531
• UDI-Public: 00889024479531
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.005
• Device Lot Number: 2809766
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other