MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 10MM MICRO; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Inadequacy of Device Shape and/or Size (1583); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during initial left shoulder arthroplasty the ten (10) mm stem implant would not seat properly into the bone.The implant sat proud by three (3) cm.The implant appeared to be oversized to an unsafe level.Another stem of nine (9) mm was used to complete the surgery.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the porous coating is visually conforming and the stem is visually conforming to the print.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The device history records for part # 113610, lot #713330 were reviewed for deviations and/or anomalies with the following related anomalies/deviations identified: f13 width being oversized on all 11 pieces.All parts were reworked.All pieces were measured and found to be in specification after the rework; therefore it is not expected that the manufacturing process contributed to the reported issue.A definitive root cause cannot be determined.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: COMP PRIMARY STEM 10MM MICRO
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9104498
• MDR Text Key: 162059634
• Report Number: 0001825034-2019-04226
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• 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: 113610
• Device Lot Number: 713330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR