MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL STEM NON-POROUS 13 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS, EXTREMITIES

Catalog Number 00435001313

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02236, 0001822565-2020-02245.Concomitant medical products: poly liner - part# 00434906506, lot# 64163174.Unk glenoid head.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 patient underwent a reverse shoulder arthroplasty approximately five (5) months ago.Approximately one (1) month post implantation, patient underwent a revision due to pain, dislocation, and the poly liner disengaging from the stem.Surgeon only removed and replaced a new poly liner.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed were reviewed and identified open reduction and revision of right rtsa humeral component, poly spacer.Presented with increased pain, x-ray showed a dislocated shoulder.Closed reduction attempted but unsuccessful.Upon opening, the humeral poly component was noted to be displaced anterior and off the humeral stem.X-rays were not sent for mmi review as they do not enhance the investigation.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.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: HUMERAL STEM NON-POROUS 13 MM STEM DIAMETER 130 MM STEM LENGTH
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10186918
• MDR Text Key: 196213232
• Report Number: 0001822565-2020-02237
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024269323
• UDI-Public: (01)00889024269323
• Combination Product (y/n): N
• PMA/PMN Number: K130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00435001313
• Device Lot Number: 63754535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention