MAUDE Adverse Event Report: ZIMMER GMBH AVENIR MULLER, STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14; AVENIR MULLER STEM

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: exceed abt e1 n/flng cup 32x54 32x54mm catalog no# ep-113254, lot no# 3538911.Concomitant medical products: therapy date: (b)(6) 2018.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received 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 or Problem Description
Patient was implanted on left side and underwent revision due to periprosthetic fracture.
Event or Problem Description
Please refer to report 0009613350 - 2018 - 01259.
Additional 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: no trend considering the following event is identified: revision due to bone fracture event description: it was reported that a patient underwent an initial hip procedure on (b)(6) 2018.Subsequently the revision procedure was performed on (b)(6) 2018 due to periprosthetic fracture.The avenir stem was revised to a long stem cemented cpt.Review of received data: undated x-ray 1 review: pelvis overview: the cup inclination angle is comparatively unchanged.Red marks the distance between the lateral shoulder of the prosthesis and the lower edge of the greater trochanter.Undated x-ray 2 review: pelvis overview: for the viewer on the right edge recognizable clip material.Compared to the previous x-ray, the stem sits lower - the relative distance between the lateral stem shoulder and lower edge of the greater trochanter is significantly smaller (red marked) the periprosthetic fracture with avulsion of the lesser trochanter fragment is easy to see.Relatively steep cup inclination angle of about 58° (blue marked).Positioning of the stem shoulder in relation to the lower edge of the greater trochanter (red marked).Compared to the previous x-ray, the foramen obturatorium is shown oval (red cross).Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: no product documentation was reviewed for investigation.Conclusion: the patient underwent revision surgery due to periprosthetic fracture after 21 days in-vivo time and the stem was revised.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Received x-ray confirms the bone fracture.Despite different rotation conditions of the femur a significant subsidence of the stem can be seen radiographically during the time in-vivo.In that sense it is likely that a wrong size was preferred for the stem during primary implantation surgery.The cup position is relatively steep, but not changed in the course.What has finally led to the periprosthetic fracture can not be reliably assessed on the basis of the available x-rays.Therefore, based on the available information, an exact root cause could not 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).

• Brand Name: AVENIR MULLER, STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14
• Common Device Name: AVENIR MULLER STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8188682
• Report Number: 0009613350-2018-01259
• Device Sequence Number: 2070398
• Product Code: LZO
• UDI-Device Identifier: 00889024479517
• UDI-Public: 00889024479517
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.004
• Device Lot Number: 2910977
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/01/2018
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 05/06/2019
• 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: Hospitalization; Required Intervention