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

Model Number N/A

Device Problems Component Missing (2306); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2014

Event Type  malfunction  

Manufacturer Narrative

The product was not available for return.Root cause could not be determined.Complaint of missing labels was deemed non-verifiable.Review of device history records found this unit was released to distribution with unrelated deviations or anomalies: pn 113630 ln 933160.Review of complaint history found no additional issues reported for this part.This event was deemed not reportable as no patient injury occurred and there was no delay in the surgery.Relayed results to biomet (b)(4) via email on (b)(6) 2014.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.This report is being submitted late as it has been identified in remediation.Zimmer biomet complaint: (b)(4).

Event Description

It was reported that patient underwent a total hip arthroplasty on (b)(6) 2014.It was discovered that labels were missing inside of the femoral stem packaging.The femoral stem was used to complete the procedure and there was no delay.

• Brand Name: COMP PRIMARY STEM 10MM MINI
• Type of Device: PROSTHESIS - SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7060417
• MDR Text Key: 93335927
• Report Number: 0001825034-2017-10585
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 113630
• Device Lot Number: 933160
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1