MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 50 MM O.D.; PROSTHESIS, HIP

Catalog Number 00500105000

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted.The investigation is in process.Once the investigation is complete, a follow ¿up mdr will be submitted.(b)(4).Concomitant medical products: item# 00500105728 liner / lot # 63794996.Item# 00625006520/ bone screw lot # 62991268.Item# 00625006515/ bone screw lot # 64217957.Item# 00625006520 / bone screw lot # 63029081.Item# 00625006515/ bone screw lot # 64700864.Item# 00625006515/ bone screw lot # 64492557.Item# 00625006520 / bone screw lot # 63029076.Item# 00625006530 / bone screw lot # 6689218.

Event Description

It was reported patient has been indicated for hip revision for unknown reasons; 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 receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: SHELL 50 MM O.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10295450
• MDR Text Key: 199488375
• Report Number: 0002648920-2020-00350
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K833991
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 00500105000
• Device Lot Number: 37216653
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other