MAUDE Adverse Event Report: ZIMMER INC SHELL WITH CLUSTER HOLES POROUS 50 MM O.D. SIZE HH FOR USE WITH HH LINERS; HIP, PROSTHESIS

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Code Available (3191)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product: unk inserter, lot#unk, item#unk.(b)(6).The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) was reviewed and no discrepancies relevant were found.Review of the complaint history determined that no further action is required.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this 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.Multiple mdr reports were filed for this event, please see associated report: 0001822565-2017-08602.

Event Description

It was reported that during a hip arthroplasty, during impaction of the acetabular shell, the shell released from the inserter prior to fixation of the shell in the acetabulum.The surgeon felt the components were initially attached correctly.No patient consequences were reported.

• Brand Name: SHELL WITH CLUSTER HOLES POROUS 50 MM O.D. SIZE HH FOR USE WITH HH LINERS
• Type of Device: HIP, PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; 800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7126618
• MDR Text Key: 95397189
• Report Number: 0001822565-2017-08599
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK091508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• 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: 00875705001
• Device Lot Number: 63432648
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other