MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. CMK O.C. REVISION MODULAR CEMENTED FEMORAL STEM 12/14 S201 L200; PROSTHESIS, HIP

Model Number N/A

Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source- foreign.The event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

The customer opened the outer paper box of the product and found that the sterile tray was damaged.In addition, the plastic bag which is wrapping the stem directly was also torn.The surgery was finished with backup product after a 15 minute delay.No further information has been made available at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d1, g4, h2, h6, h10.Complaint sample was evaluated and the reported event was confirmed.The product was received and a product analysis was performed.During the product analysis it was identified that the blister was broken and some pieces have fallen on the folding box.Also, the stem was not under vacuum.The inner pouch was damaged on the fold area, leading on the breach.According to the available data, the most probable root cause of the event is a transport issue.This complaint could be reopened if further information is received later if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the customer opened the outer paper box of the product and found that the sterile tray was damaged.In addition, the plastic bag which is wrapping the stem directly was also torn.The surgery was finished with backup product.No adverse events have been reported as a result of the malfunction.

Event Description

It was reported that the customer opened the outer paper box of the product and found that the sterile tray was damaged.In addition, the plastic bag which is wrapping the stem directly was also torn.The surgery was finished with a backup product after 15 minutes delay.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed.The evaluation of the returned device found that the inner pouch was damaged and the blister was broken.The review of the device manufacturing quality record indicates that (b)(4) products cmk revision stem cemented modular 12/14 201 l200, reference (b)(4), batch 0001096902 were manufactured on february 16, 2016.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the complaint issue.No other similar complaints has been recorded for, reference (b)(4), batch 0001096902 within one year.With the available information, the exact root cause of the event could not be determined.An investigation has been performed, consisting of a documentary review and product analysis.The documentary review showed that the product was manufactured according to the pre-defined specifications of biomet france.The product analysis confirmed the event.According to available data, the exact root cause can¿t be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CMK O.C. REVISION MODULAR CEMENTED FEMORAL STEM 12/14 S201 L200
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 7205201
• MDR Text Key: 98064265
• Report Number: 3006946279-2018-00012
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2021
• Device Model Number: N/A
• Device Catalogue Number: 3553.291-200
• Device Lot Number: 0001096902
• Other Device ID Number: (01) 03599870016138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1