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 Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

X-rays were received and will be reviewed as part of ongoing investigation.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 after a surgery on (b)(6) 2017 the patient labels which can be found inside the avenir packaging did not correspond with the label on the outside of the packaging.The actual information received does not clearly mention if the patient was implanted with the desired implant.It was also reported that the surgery was successfully completed and no patient harm has been reported.It is unclear whether: (avenir mueller, stem, lateral, uncemented, ha, 4, taper 12/14 ref# 01.06010.104) or (avenir mueller, stem, standard, uncemented, ha, 3, taper 12/14 ref# 01.06010.003) was implanted.- patient label received ref# 01.06010.104 lot# 2905496.- outside packaging ref# 01.06010.003 lot# 2904368.

Manufacturer Narrative

Avenir mueller, stem, standard, uncemented, ha, 3, taper 12/14, item#: 01.06010.003, lot#: 2904368 (only packaging).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: (b)(4) (case at hands, wrong label inside the packaging) (b)(4) (issue related to a missing label inside the packaging).An issue evaluation has been performed (see below).Device history records (dhr): patient label: lot#: 2905496, ref#:01.06010.104.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Packaging label: lot#: 2904368, ref#: 01.06010.003.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 after a surgery (when re-ordering product) it was detected that the patient label which can be found inside the avenir packaging did not correspond with the label on the outside of the packaging.Review of received data: two x-rays of the implanted stem have been received.The implanted stem was assessed with comparing the x-rays to the applicable drawings of both stems.It could be determined that item# 01.06010.104 (lot 2905496) was implanted (avenir size 4 lateral).Devices analysis: no product was returned to zimmer biomet.The stem is still implanted.It was reported that the packaging was discarded by the hospital.Review of product documentation: it was 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 it was reported that after a surgery the patient label which can be found inside the avenir packaging did not correspond with the label on the outside of the packaging.The two received x-rays of the implanted stem have been assessed.Comparing the x-rays to the applicable drawings it could be determined that the avenir müller stem 4 lateral with item number 01.06010.104 (lot 2905496) was implanted.An issue evaluation has been performed.The purchase orders were reviewed.2 purchase orders were applicable: purchase order (po) (b)(4) on 28.04.2017 included (b)(4) pieces of size 3 (01.06010.003, lot# 2904368).39 devices have been delivered.Purchase order (po) (b)(4) on 03.05.2017 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 08.06.2017.In the case at hands affecting the inner and outer label, it is mentioned that the labels do 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.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.Lt was found out that the doctor intended to implant product 01.06010.003 (size 3 avenir stem, standard) but due to packaging product mix-up, the surgeon implanted product 01.06010.004 (size 4 avenir stem, lateral), therefore the product was non-conforming to specification.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).

Event Description

It was reported that it was detected after a surgery that the patient labels which can be found inside the avenir packaging did not correspond with the label on the outside of the packaging.The packaging was labelled with an avenir stem size 3, standard (ref: 01.06010.003 lot: 2904368) and the labels inside marked with an avenir stem size 4, lateral (ref: 01.06010.104 lot: 2905496).No patient harm has been reported.During investigation, it could be determined based on post-operative x-rays that the avenir stem size 4, lateral has been implanted.Planned product for surgery: size 3 standard.Label outside: size 3 standard.Product inside the packaging: size 4 lateral.Product label inside the box: size 4 lateral.Product implanted: size 4 lateral.

• 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: 7099290
• MDR Text Key: 95078307
• Report Number: 0009613350-2017-01713
• 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: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• 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: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 67 YR