MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TM REVERSE BASE PLATE INSERTER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 06/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product-baseplate catalog#: 00434901500 lot#: 63662493.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-04621.

Event Description

It is reported that during a reverse total shoulder arthoplasty, while the surgeon attempted to insert the baseplate with the impactor, the two parts would not disengage from each other.The baseplate was removed from the patient and the surgery was successfully completed with a new, larger 25mm baseplate.There was a delay of approximately fifteen (15) minutes to the procedure.No further patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Baseplate and baseplate inserter was provided for evaluation.Instrument was washed and we have received the instrument in disassembled condition.It is possible that some tissues or debris might have create interference fit.Dimensions taken are within specifications as documented on attached prints.Items were test assembled together and held as intended, and released as intended.The picture provided by complainant shows that the baseplate and baseplate inserter are assembled together.A definite root cause cannot be determined with the information provided.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 REVERSE BASE PLATE INSERTER
• 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: 6690986
• MDR Text Key: 79209364
• Report Number: 0001822565-2017-04622
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121543
• 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: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00430904401
• Device Lot Number: 62433883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: REFERENCE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 126