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

Model Number N/A

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: catalog #: 00434904003, poly liner plus 3 mm offset 40 mm diameter, lot # 64531924, catalog #: 00434901013, humeral stem 10 mm stem diameter 130 mm, lot # 64916336, catalog #: 00430902800, liner impactor 40 mm, lot # unknown.Report source- (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01658, 0001822565-2021-01660.Returning.

Event Description

It was reported when we tried to impact the offset poly onto the stem, the surgeon couldn't make it fit, as there appeared to be a an issue with the poly fitting to the stem.The poly liner seemed to have an incorrect shape.We tried a subsequent poly which also failed with the same problem.In the end we used a 9mm spacer with a 0mm offset poly.Had to try a second poly, then use a spacer and new poly liner and use cerclage wires and because of the excessive impacting of a malshaped poly the humeral bone fractured.Delay of 20 minutes occured.They had to try a second poly, then use a spacer and new poly liner and use cerclage wires.Attempts have been made and there is no further information at this time.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was confirmed as visual examination of the returned products identified both liners exhibited damage/witness marks on the backside at the slot indicating they were not properly aligned during the attempts to install.Both slot widths were conforming to print specifications.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to use error, misalignment of poly liners to the humeral stem.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 3 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: 12011189
• MDR Text Key: 256723833
• Report Number: 0001822565-2021-01659
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00809024259140
• UDI-Public: (01)00809024259140(17)280331(10)64531924
• Combination Product (y/n): N
• PMA/PMN Number: K052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00434904003
• Device Lot Number: 64531924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Weight: 86