MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLY LINER PLUS 6 MM OFFSET 36 MM DIAMETER; PROSTHESIS,SHOULDER

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Deformity/ Disfigurement (2360); Disability (2371); No Information (3190)

Event Date 05/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the patient underwent a revision procedure three months post-implantation due to disassociation.Attempts have been made and no further information has been made available at this time.

Event Description

It was reported the patient underwent a revision procedure due to disassociation of the poly liner three months post-implantation.No further information has been provided.

Manufacturer Narrative

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.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.

Manufacturer Narrative

Root cause remains undetermined.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.

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a revision procedure three months post-implantation due to disassociation, disability, disfigurement and pain.Attempts have been made and no further information has been made available at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of the medical records.As per the medical records, at approximately 3 months post-op, the patient was seen in the office for pain in left shoulder/arm that radiated to small finger and grinding sensation.X-ray images were taken and found that the poly had disengaged.The poly was removed and a new poly implanted.Dhr was reviewed and no discrepancies were found.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.

• Brand Name: POLY LINER PLUS 6 MM OFFSET 36 MM DIAMETER
• Type of Device: PROSTHESIS,SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7480664
• MDR Text Key: 107144875
• Report Number: 0001822565-2018-02392
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: PK130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• 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: 00434903606
• Device Lot Number: 63500072
• Other Device ID Number: (01) 00889024269071
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 00434901213 HUMERAL STEM, LOT 62952503.; 00434903611 GLENOSPHERE, LOT 63466856.; 0104223030 REVERSE, SCREW SYSTEM,, LOT 2708835.; 0104223033 REVERSE, SCREW SYSTEM, LOT 2857358.; 00434901213 HUMERAL STEM, LOT 62952503; 00434903611 GLENOSPHERE, LOT 63466856; 0104223030 REVERSE, SCREW SYSTEM,, LOT 2708835; 0104223033 REVERSE, SCREW SYSTEM, LOT 2857358
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 73