MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COCR FEM HD 40MM TYPE 1 +9MM; PROSTHESIS, HIP

Catalog Number 010001032

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Ep-108525- e-poly liner- 181790, 21-109268- ha par-5 acet shl- 779130, x12-171313- integral/x por red- 299620, 31-109200- par-5 flange prov sz short lt- 307940, 109206- par-5 flange sz short neutral- 299720,, 31-323230-rnglc+ acet drl bit- 784290, 103532- ti low profile screw- 678040, 31-323220-rnglc+ acet drl bit- 031580, 103531- ti low profile screw- 558060103531- ti low profile screw- 633300.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05112, 0001825034 - 2019 - 05114, 0001825034 - 2019 - 05115.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.

Event Description

It was reported patient has been indicated for revision due to unknown reason; however, no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: COCR FEM HD 40MM TYPE 1 +9MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9311944
• MDR Text Key: 166785558
• Report Number: 0001825034-2019-05113
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• 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: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2023
• Device Catalogue Number: 010001032
• Device Lot Number: 3147102
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other