MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLY LINER PLUS 0 MM OFFSET 40 MM DIAMETER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Detachment Of Device Component (1104); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 12/14/2017

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 four months post-implantation due to disassociation.The poly disassociated from the stem.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Product code: fda code - phx.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event 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 the patient is a morbidly obese with a diagnosis of left rotator cuff tear arthropathy.Patient presents to clinic four months following surgery with complaints of shoulder instability.Patient has a paralyzed right upper extremity and engages in fairly extreme ranges of motion with his left arm to care for himself including trying to reach behind his back and across the body frequently.It was noted that the patient dislocated.At the time of the revision surgery, the polyethylene was not dissociated from the stem.The patient was upsized to a 12 mm spacer with a +6 retentive liner.Four months following the revision surgery, the patient experienced a dislocated reverse arthroplasty.The patient was revised immediately as the polyethylene dissociated from the humeral stem.The stem was extracted and cemented.A 12 mm spacer was placed with a +3 retentive liner.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

• Brand Name: POLY LINER PLUS 0 MM OFFSET 40 MM DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7480794
• MDR Text Key: 107152118
• Report Number: 0001822565-2018-02296
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: PK052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2018

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 Expiration Date: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00434904000
• Device Lot Number: 63364070
• Other Device ID Number: (01) 00889024269132
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 05/30/2018; 06/21/2018
• Supplement Dates FDA Received: 06/20/2018; 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR