MAUDE Adverse Event Report: ZIMMER GMBH AVENIR MULLER, STEM, LATERAL, UNCEMENTED, HA, 7, TAPER 12/14

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: biolox delta, ceramic femoral head, m, 36/0, taper 12/14, catalog no#: 00-8775-036-02, lot#: 2946139.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 for the explanted devices, 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 has been implanted on right side and underwent revision due to periprosthetic fracture.
Additional Manufacturer Narrative
Investigation results were made available.Dhr-review: ref:01.06010.107 ; lot:2924249 - yield:40 - delivered:39 - scrapped:01 - reason for scrapping:surface damages 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: bone fracture event description: it was reported that the avenir müller stem was revised 6 days after implantation due to periprosthetic fracture which may have occurred intraoperatively.Review of received data: - 1 x-ray dated (b)(6) 2018 is received for the investigation.It can not be said with certainty whether a fracture or fissure can be detected in the area of the stem.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment./ all involved devices are intended for treatment.- surgical technique was not reviewed as no surgical report was received to compare whether the surgical technique was followed or not.Conclusion summary: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The investigation results did not identify a non-conformance or a complaint out of box (coob).In the case of a mismatch between the stem and the femur, it is possible in principle for a fissure or fracture to occur during cementless stem implantation.However, it is unknown whether the bone fracture occurred during operation or after the operation.The received x-ray did not confirm any existence of a bone fracture.Based on the given information the complaint could not be confirmed.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 or Problem Description
Investigation results are now available.
Additional Manufacturer Narrative
Additional information was received.Concomitant medical products: associated item number: 00877503602.Item name: biolox delta, ceramicfemoral head, m, 36/0, taper 12/14.Lot #2946139.Associated item number: 12-115121.Item name: cer bioloxd mod hd 36mm std nk.Lot # 2943888.Associated item number: 010000668.Item name.G7 pps ltd acet shell 62h.Lot # 3881609.Associated item number: 010000860.Item name: g7 neutral e1 liner 36mm h.Lot # 3873835.Associated item number: 11-300818.Item name: arcos 18x150mm spl tpr dist m.Lot # 842240.Associated item number: 11-301353.Item name: arcos con sz c hi 80mm m sz c.Lot # 729060.Associated item number: 00223200418.Item name: cable cerclage cable with crimp 1.8 mm dia.635 mm length.Lot # 64123314.Associated item number: 00223200418.Item name: cable cerclage cable with crimp 1.8 mm dia.635 mmlength.Lot # 6412331.X-rays were received and will be reviewed within investigation process.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 event update.

• Brand Name: AVENIR MULLER, STEM, LATERAL, UNCEMENTED, HA, 7, 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: 8150613
• Report Number: 0009613350-2018-01213
• Device Sequence Number: 268388
• Product Code: LZO
• UDI-Device Identifier: 00889024479548
• UDI-Public: 00889024479548
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2019

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: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.107
• Device Lot Number: 2924249
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 11/29/2018; 06/24/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 12/12/2018; 06/26/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 141