MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS 25MM BSPLT HA+ADPTR; SHOULDER, PROSTHESIS

Catalog Number 010000589

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Procode: phx.Concomitant medical products: comp lk scr 3.5hex 4.75x35 st cat: 180554 lot: 082900, 36mm vit e liner +0mm cat: 36mm vit e liner +0mm lot: 64093863, comp rvrs shldr glnsp std 36mm cat: 115310 lot: 808580, humeral stem 12 mm stem diameter 130 mm stem length cat: 00434901213 lot: 64141144, comp nlk scr 3.5hex 4.75x25 st cat: 180559 lot: 094860, comp lk scr 3.5hex 4.75x15 st cat: 180550 lot: 157510.Report source: foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported that the patient was revised due to implant fracture and dislocation.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.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

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.

• Brand Name: COMP RVRS 25MM BSPLT HA+ADPTR
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9162347
• MDR Text Key: 167191505
• Report Number: 0001825034-2019-04516
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K120121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 010000589
• Device Lot Number: 994100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention