MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TM HUMERAL STEM SPACER SIZE 9; PROSTHESIS, SHOULDER,

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

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

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Concomitant medical products- zimmer tm reverse poly liner catalog#: 00434904003 lot#: 63600125, zimmer tm reverse poly liner catalog#: 00435004003 lot#: 63122824, zimmer tm humeral stem catalog#: 00434901013 lot#: 63642081, zimmer tm reverse humeral spacer catalog#: 00434903909 lot#: 63615205.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: 0001822565-2017-04633, 0001822565-2017-04632, 0001822565-2017-04631, 0001822565-2017-04630.

Event Description

It was reported that during a reverse total shoulder arthroplasty the polyethylene liner would not seat into the spacer after impacting it multiple times.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was unable to be confirmed.Inspection of the returned device revealed the spacer was assembled to the stem.Attempt was made to disassemble the spacer from the stem but was unsuccessful.Per the mis the tapers need to be measured on the machine and hence taper diameter measurements was not taken.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not be determined.A summary of the investigation has been sent to the complainant.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: ZIMMER TM HUMERAL STEM SPACER SIZE 9
• Type of Device: PROSTHESIS, SHOULDER,
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6692729
• MDR Text Key: 79267773
• Report Number: 0001822565-2017-04633
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00434903909
• Device Lot Number: 63615205
• Other Device ID Number: (01) 008890244269118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2017
• 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
• Patient Age: 60 YR