MAUDE Adverse Event Report: ZIMMER, INC. VERSYS FIBER METAL MID COAT FEMORAL STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has 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.Concomitant medical products: unknown head.Unknown cup.Unknown liner.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-06249.

Event Description

It was reported that a patient underwent an initial hip procedure.Subsequently, the patient was revised due to metallosis and elevated metal ion levels.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.00620205622 shell porous with cluster holes 56 mm lot 62883561 00630505636 liner standard 3.5 mm offset 36 mm i.D.For use with 56 mm o.D.Shell lot 63127905 00625006540 bone screw self-tapping 6.5 mm dia.40 mm length lot # 63077865 reported event was unable to be confirmed due to limited information received from the customer.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 as the necessary information to adequately investigate the reported event was not provided.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 a patient was revised and is experiencing pain post operatively.No further information is available at this time.

Manufacturer Narrative

The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Upon receipt of additional information it was found.

• Brand Name: VERSYS FIBER METAL MID COAT FEMORAL STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6842773
• MDR Text Key: 84873638
• Report Number: 0001822565-2017-06250
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK922071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00784101450
• Device Lot Number: 63077052
• Other Device ID Number: (01) 00889024136151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 09/05/2017
• Supplement Dates Manufacturer Received: 12/01/2017; 01/09/2018
• Supplement Dates FDA Received: 12/29/2017; 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention