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

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.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 Description

It was reported that during surgery on (b)(6) 2017 the patient labels inside the packaging of an avenir müller, stem, lateral, uncemented, ha, 4, taper 12/14 were missing.It was also reported that the implant was used.No harm or injury to patient was reported.

Manufacturer Narrative

Trend analaysis: a trend considering the following event was identified: wrong (or missing) label in the packaging.2 similar investigated events for the lot number 2905496 have been found.The following complaints are considered: - cmp-0349886 (case at hands, missing label inside the packaging).- cmp-0346080 (wrong label inside the packaging) an issue evaluation has been performed (see below).Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Review of event description: it was reported that the patient labels inside the packaging of an avenir stem were missing.Devices analysis: no product was returned to zimmer biomet.The stem has been implanted.Review of product documentation: the case at hands is related to a missing label inside the packaging.The same reference number and lot number is mentioned in another case (cmp-0346080), where it is reported that the inner and outer label does not correspond to each other.The inner and outer labels are not congruent and give different information about the sizes and shape ("standard" versus "lateral") of the content of the package.- item# 01.06010.104, lot 2905496: manufacturing date 19.04.2017, - item# 01.06010.003, lot 2904368: manufacturing date 13.04.2017.An issue evaluation has been performed.The purchase orders were reviewed.2 purchase orders were applicable: - purchase order (po) 4501738614 on (b)(6) 2017 included 39 pieces of size 3 (01.06010.003, lot# 2904368).39 devices have been delivered.- purchase order (po) 4501744107 on (b)(6) 2017 included 39 pieces of size 4 (01.06010.104, lot# 2905496) but only 38 have been delivered, 1 device was scrapped due to a scratched surface.Both po were sent separately to the supplier medicoat but at medicoat both orders were packed and labeled on (b)(6) 2017.In the case at hands, the issue is related to a missing label inside the packaging.In another case (cmp-0346080), it is mentioned that the labels do not correspond to each other.As both batches have been packaged and labelled at supplier medicoat at the same day (june 08, 2017) it is assumed that there was a line clearance issue at the supplier medicoat which lead to a label mix-up and a missing label in the packaging.A scar (supplier corrective action request) was initiated on february 23rd, 2018 to address the issue at supplier medicoat.The field action fa 2018-02 (zfa2018-23) has been initiated.Zimmer gmbh is conducting a voluntary medical device field action (removal of all remaining implants in the markets) for the two specific lot numbers lot# 2905496 and lot# 2904368.Investigation revealed that there is a potential product mix up within the packaging between avenir muller stem size 3, standard and avenir muller stem size 4, lateral.As a precautionary measure it was decided to remove all remaining implants in the markets.All affected hospitals and surgeons that have received these products have been notified.Note: the affected lots were not distributed in usa.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: AVENIR MÜLLER, STEM, LATERAL, UNCEMENTED, HA, 4, TAPER 12/14
• Type of Device: AVENIR MULLER STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7141495
• MDR Text Key: 95635890
• Report Number: 0009613350-2017-01835
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK123392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.104
• Device Lot Number: 2905496
• Other Device ID Number: 00889024479500
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 03/28/2018
• Supplement Dates FDA Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1