MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLY LINER PLUS 3 MM OFFSET 40 MM DIAMETER; PROSTHESIS, HIP

Model Number N/A

Device Problems Detachment Of Device Component (1104); Unstable (1667); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 09/28/2017

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.Discarded.

Event Description

It was reported that a patient underwent a revision procedure approximately nine months post-implantation due to dissociated poly.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Concomitant medical product: base plate, cat#: 00434902502, lot#: ni.Anatomical reverse screw system, cat#: 0104223042, lot#: ni.Anatomical reverse screw system, cat#: 0104223048, lot#: ni.Glenosphere, cat#: 00434904011, lot#: ni.Humeral stem, cat#: 00434901013, lot#: ni.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.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 presented with complaints of shoulder instability at eight months post-implantation.Patient underwent a revision procedure approximately nine months post-implantation due to instability.Patient's liner was partially disassociated at the time of surgery.Liner was replaced with a retentive liner and has had no further issues.

• Brand Name: POLY LINER PLUS 3 MM OFFSET 40 MM DIAMETER
• 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: 7480204
• MDR Text Key: 107132001
• Report Number: 0001822565-2018-02391
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

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: 00434904003
• Device Lot Number: 63381083
• Other Device ID Number: (01) 00889024269149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 06/18/2018
• Supplement Dates FDA Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2016
• 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; Required Intervention
• Patient Age: 70 YR