MAUDE Adverse Event Report: ZIMMER, INC. ZCA ALL-POLY ACETABULAR CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).(b)(6).

Event Description

After preparation of the acetabulum using the correct surgical technique, the implant was mounted onto the impactor.Prior to cementing the implant, it was placed into the acetabulum to check for alignment.Upon lifting the implant back out, it was noted that two of the spacers had fallen off the implant and into the patient.One of the spacers were located but the other one was not found.A second implant was opened and implanted.There was not a significant delay as a result of the event.Attempts to obtain additional information have been made; however, none is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further actions are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: ZCA ALL-POLY ACETABULAR CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6566770
• MDR Text Key: 75143449
• Report Number: 0001822565-2017-03005
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK901240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00800554832
• Device Lot Number: 63421820
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/15/2017
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR