MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM SHOULDER STEMS; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Osteolysis (2377)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mfr#0001822565-2018-02091, mfr#0001822565-2018-02093.Concomitant medical products: bigliani/flatow offset modular humeral head pn00430205221 ln62825742.Bigliani/flatow glenoid component pn00430008200 ln60919038.(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of sterilization certification confirms devices were sterilized in accordance with iso 11137-2.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

It was reported that the patient underwent an initial left total shoulder arthroplasty.Subsequently, the patient underwent revision two years later due to infection and osteolysis.All implants were removed and a spacer was inserted.The surgeon intends to implant a total reverse shoulder in 6 weeks.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined that this device was not involved in the event.The initial report was submitted in error and should be voided.

Manufacturer Narrative

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: TM SHOULDER STEMS
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7443543
• MDR Text Key: 105935770
• Report Number: 0001822565-2018-02092
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: PK041549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00434811713
• Device Lot Number: 61665209
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 124