MAUDE Adverse Event Report: ZIMMER, INC. CPT HIP SYSTEM CENTRALIZER; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during surgery, the cpt centralizer did not seat to the cpt stem.

Manufacturer Narrative

Concomitant medical products- unknown stem.Report source: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the centralizer exhibits three wear marks can be observed on the cylindrical base of the centralizer evenly spaced between the 3 legs.One of the legs also exhibits a mark where the material was flexed beyond the limit of elasticity.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were 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.

Event Description

It was reported that during surgery, the cpt centralizer did not seat to the cpt stem.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: CPT HIP SYSTEM CENTRALIZER
• 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: 6338644
• MDR Text Key: 67654775
• Report Number: 0001822565-2017-00926
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK811416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 32833305500
• Device Lot Number: 60934344
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1