MAUDE Adverse Event Report: ZIMMER GMBH AVENIR, STEM, LATERAL, CEMENTED, 3, TAPER 12/14; AVENIR CEMENTED HIP STEM

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Debris, Bone Shedding (1803)
Date of Event	08/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no lot number was provided, the device history records could not be reviewed.The manufacturer received x-rays and other source documents for review.The device has not been received for investigation as the patient has not been revised.Additional information has been requested and is currently not 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 or Problem Description
It was reported that a fissure in the calcar area of the femur occurred during insertion of a cemented avenir shaft.
Event or Problem Description
No event update.
Additional Manufacturer Narrative
It was reported that the surgical technique was followed.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
No change to previously reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: it was reported that during the implantation surgery of an avenir stem on (b)(6) 2018 a fissure in the calcar area of the femur occurred after the insertion of the stem.Review of received data: the undated received x-ray shows the right thr with a cemented stem fixed by a cerclage cable at the mid height of the stem.No abnormalities observed.The surgery report dated (b)(6) 2018 was reviewed.Devices analysis: no product was returned to zimmer biomet for in-depth analysis as it remains implanted.Review of product documentation compatibility: compatibility check could not be performed as only one product had been reported.Conclusion summary during the implantation of a cemented avenir stem, a fissure occurred intraoperatively at the area of the medial calcar which was fixed with a cerclage cabel.According the surgical report, after unsatisfying positioning of rasp size 4 surgeon decided to go for a size 3 stem.Size 3 rasp had a good place, however, the insertion of the size 3 cemented stem led to a fissure which did not go deep until the stem but stayed distal.Stem was not received for product investigation to check the dimensions since it is kept implanted.However, the quality records of the stem show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Possible causes of the bone fracture include excessive force applied on the bone during rasping, trial reduction or impaction of the stem into femur.It is possible that the unsatisfying position of rasp size 4 occured due to very hard bone conditions.It is unknown whether the surgeon used the correct rasp handle with the preferred rasps and also correct stem inserter.Surgical report do not indicate the use of those instruments.Therefore, wrong handling of instrumentation is another possible cause of the reported event.Therefore, based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.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, STEM, LATERAL, CEMENTED, 3, TAPER 12/14
• Common Device Name: AVENIR CEMENTED HIP STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8046150
• Report Number: 0009613350-2018-01140
• Device Sequence Number: 1653967
• Product Code: LZO
• UDI-Device Identifier: 00889024479623
• UDI-Public: 00889024479623
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K131884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 01.6010.03
• Device Lot Number: 2945289
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 11/13/2018; 04/05/2019
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 12/06/2018; 04/12/2019
• 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