MAUDE Adverse Event Report: ZIMMER, INC. SHELL POROUS WITH HOLES 50 MM O.D. WITH CALCICOAT CERAMIC COATING; PROSTHESIS, HIP

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).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.

Event Description

It was reported that the acetabular shell could not be firmly fixed into the hybrid shell inserter.The backup shell was able to fix easily.

Manufacturer Narrative

Cmp-(b)(4).This follow-up report is being submitted to relay additional information.The following sections have been updated: reported event was confirmed by review of actual device received.Device history record (dhr) was reviewed with no deviations.The root cause of the reported event can be attributed to the surgeon not using the adapter with rotational control during the procedures.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.

Event Description

No further event information available at the time of this report.

• Brand Name: SHELL POROUS WITH HOLES 50 MM O.D. WITH CALCICOAT CERAMIC COATING
• 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: 6609086
• MDR Text Key: 76588744
• Report Number: 0001822565-2017-03806
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK980711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

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: 65620005020
• Device Lot Number: 63549319
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2016
• 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): Other