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

Catalog Number 3553.291-200

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

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.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 has been reported that the sterile package was cracked.

Event Description

It has been reported that the sterile package was cracked.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.The device has been returned to the manufacturer.The device analysis showed that the sealing of the inner packaging was damaged.With the available information, the exact root cause of the event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It has been reported that the sterile package was cracked.There was no patient involvement.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay correction information.The following section has been updated : g4, h2, h10 the reported event was confirmed by the product analysis.The product was received and a product analysis was performed.The blister was cracked.The defect was around 2 cm length.The review of the device manufacturing quality record indicates that (b)(4) products designation cmk revision stem, reference 3553.291-200, lot number 0000967631 were manufactured on 10 november 2014.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 event described in the complaint.No similar complaint has been recorded for batch 0000967631 on the reported event within one year.According to the available data, the most probable root cause of the event is a transport issue a summary of the investigation was sent to the complainant conveying zimmer biomet conclusions.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: 7855452
• MDR Text Key: 119934460
• Report Number: 3006946279-2018-00309
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2019
• Device Catalogue Number: 3553.291-200
• Device Lot Number: 0000967631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• 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