MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 52 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Concomitant medical products: item number: unknown, item name: unknown head, lot #: unknown, item number: unknown, item name: unknown liner, lot #: unknown, item number: unknown, item name: unknown stem, lot #: unknown.Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The product remains implanted.

Event Description

It was reported that during an initial hip arthroplasty the liner was unable to seat into the shell.Upon closer inspection it was noted that the locking ring on the shell was displaced.After the locking ring was repositioned the surgery was completed successfully with the shell.Surgery was delayed approximately 10 minutes.No patient harm was indicated.No additional information is available at this time.

Manufacturer Narrative

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

Event Description

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

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 52 MM O.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8884185
• MDR Text Key: 153993731
• Report Number: 0001822565-2019-03420
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00620005222
• Device Lot Number: 63834170
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1