MAUDE Adverse Event Report: ZIMMER, INC. CONTINUUM LONGEVITY LINER; HIP PROSTHESIS

Model Number N/A

Device Problems Detachment Of Device Component (1104); Difficult to Insert (1316); Difficult To Position (1467)

Patient Problem No Code Available (3191)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that during surgery, the shell and liner could not be implanted and well fitted.The surgery was completed with the method of cementing other devices.

Manufacturer Narrative

Concomitant medical product(s): 00875304801 shell with cluster holes porous 48 mm o.D.Size gg for use with gg liners 63102873.The complaint sample returned was evaluated and the complaint is confirmed.Visual inspection of the product returned shows extensive damage to the scallops, rim feature and taper so no analysis was performed.Device history records are reviewed and no anomalies or deviations that would have affected the surgical outcome or contributed to the reported event were found, a root cause cannot be identified, with the information 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-02736.

Event Description

It is reported that during surgery, the shell and liner could not be implanted and well fitted.The surgery was completed with the method of cementing other devices.The liner disassociated from the cup during the range of motion.Hence the cup and liner was exchanged intra-operatively.

• Brand Name: CONTINUUM LONGEVITY LINER
• Type of Device: HIP PROSTHESIS
• 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: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5865810
• MDR Text Key: 51771490
• Report Number: 0001822565-2016-02737
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PK151448
• 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
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00875200832
• Device Lot Number: 63144845
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2015
• 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): Other
• Patient Age: 71 YR
• Patient Weight: 50