MAUDE Adverse Event Report: ZIMMER GMBH AVENIR MLLER STEM 1 STANDARD; AVENIR MULLER STEM

Model Number	N/A
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy date detail of product: item number 01.06010.302, item name avenir stem lat cemented 2, lot # unknown.Item number 00877503202, item name biolox⮠delta, ceramic femoral head, m, 㸠32/0, taper 12/14, lot # 2939555.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.(b)(4).
Event or Problem Description
It was reported that revision surgery was planned without cementing, but was not possible.The desired stem had to be cemented.
Additional Manufacturer Narrative
Since this event does not represent an issue regarding the product but rather an issue regarding the product-portfolio, this case does not fulfill the criteria of a complaint anymore.This case will be invalidated.Please delete this case from your database as it will be invalidated.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
It was now reported from the clinic that there was no suitable cementless shaft size.Size 1 was too small, size 2 was too big.For this patient a size of 1.5 would be suitable, but this size does not exist.The surgery was finished after the implantation of the cemented avenir stem ¿ size 2.It was therefore reported that there was no malfunction of a zimmer biomet product.The product (avenir stem cemented ¿ size 2) has been implanted according to surgical technique.Since this event does not represent an issue regarding the product but rather an issue regarding the product-portfolio, this case does not fulfill the criteria of a complaint anymore.This case will be invalidated.

• Brand Name: AVENIR MLLER STEM 1 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: 9074342
• Report Number: 0009613350-2019-00569
• Device Sequence Number: 2529102
• Product Code: LZO
• UDI-Device Identifier: 00889024479456
• UDI-Public: 00889024479456
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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
• Patient Age: 80 YR
• Patient Weight: 48