MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD STEM - 10X75MM; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(udi): n/a.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Unknown.

Event Description

It was reported the patient underwent an initial shoulder surgery at an unknown date.Subsequently the patient has been indicated for a revision due to a broken locking screw, however, a revision has not been reported.

Event Description

It was further reported that the patient was undergoing a revision (from non zb products).During the revision the incorrect impactor was used and the screw broke.Another stem was opened to used the screw packaged with and the surgery was completed.No patient harm.No delay in surgery.

Manufacturer Narrative

(b)(4).H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : discarded.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.It was reported that the incorrect inserter was used and the screw broke.However, without any additional details for the inserter a definitive root cause cannot be identified.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

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

• Brand Name: COMPR SRS MOD STEM - 10X75MM
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10419711
• MDR Text Key: 203304720
• Report Number: 0001825034-2020-03213
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K173411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 211232
• Device Lot Number: 659900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 08/28/2020; 12/15/2020
• Supplement Dates FDA Received: 09/01/2020; 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention