MAUDE Adverse Event Report: ZIMMER GMBH FITMORE SHL W SCR CONES 50/HH

Model Number N/A

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

Patient Problems Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products and therapy date detail of product: item number unknown.Item name avenir stem.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 (b)(6) registry because one patient underwent revision surgery due to dislocation.

Manufacturer Narrative

Additional information which was received on nov 13, 2019.Medical product: cocr head 32/0 med 12/14; item#: 14320620; lot#: 2804223; dural alpha insert neutr hh/32; item#: 0100013408; lot#: 2799256; avenir muller stem 5 standard; item#: 0106010005; lot#: 2809766; countersunk cancell scr 6.5/25; item#: 421925; lot#: unknown; countersunk cancell scr 6.5/19; item#: 421920; lot#: 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 or 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 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: 0009613350-2019-00786, 0009613350-2019-00772, 0009613350-2019-00774.

Event Description

No change to previously reported event.

• Brand Name: FITMORE SHL W SCR CONES 50/HH
• Type of Device: FITMORE SHL W SCR CONES 50/HH
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9294930
• MDR Text Key: 165560844
• Report Number: 0009613350-2019-00663
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 01/21/2020

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: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 01.00024.550
• Device Lot Number: 2793934
• 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