MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL STEM 10 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 00434904003, poly liner plus 3 mm offset 40 mm diameter, lot # 64531924; catalog #: 00434904003, poly liner plus 3 mm offset 40 mm diameter, lot # 64531924; catalog #: 00430902800, liner impactor 40 mm, lot # unknown.Report source- (b)(6).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, 0001822565-2021-01659.Returning.
Event or Problem 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 or Problem Description
No further event information available at the time of this report.
Additional 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: HUMERAL STEM 10 MM STEM DIAMETER 130 MM STEM LENGTH
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12011312
• Report Number: 0001822565-2021-01660
• Device Sequence Number: 11864312
• Product Code: HSD
• UDI-Device Identifier: 00889024268937
• UDI-Public: (01)00889024268937(17)301201(10)64916336
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00434901013
• Device Lot Number: 64916336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 86