MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAXERA CUP IMPACTOR 48MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign ¿ events occurred in (b)(6).Customer has been indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the instrument was found cracked during sterilization.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.A maxera cup impactor was returned for evaluation.As returned, metal debris is embedded in the impactor cap.Deep gouges are seen on the cap.Dimensional measurements are conforming to print specifications.The device exhibits wear & tear that indicates successful use during a potential field age of approximately 4 years 8 months.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to 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.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.A maxera cup impactor was returned for evaluation.As returned, metal debris is embedded in the impactor cap.Deep gouges are seen on the cap.Dimensional measurements are conforming to print specifications.The device exhibits wear & tear that indicates successful use.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.Root cause was unable to 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: MAXERA CUP IMPACTOR 48MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6998869
• MDR Text Key: 91246693
• Report Number: 0001822565-2017-07574
• Device Sequence Number: 1
• Product Code: NLF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00151603048
• Device Lot Number: 62283843
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1