MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER SEGMENTAL DISTAL FEMORAL COMPONENT SIZE B LEFT; PROSTHESIS, KNEE

Catalog Number 00585001201

Device Problem Device Packaging Compromised (2916)

Patient Problem No Code Available (3191)

Event Date 04/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent an initial total knee arthroplasty.During the procedure it was noticed that the packaging of the femoral component was compromised.A different sized femoral was used, but additional removal of the tibia had to be done in order for the compatible articular surface to fit.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The femoral component packaging was returned and from the returned packaging it was determined that, the inner and outer cavities are cracked and the outer carton exhibits transit damage.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.The cracked cavities damage can be caused due to the outside forces during transit or the forces due to the implant.As the outer carton exhibiting damage, the transit may be the cause of the damage.So the root cause of the reported issue attributed to be package damaged during shipping / transit damage.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: ZIMMER SEGMENTAL DISTAL FEMORAL COMPONENT SIZE B LEFT
• Type of Device: PROSTHESIS, KNEE
• 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: 6598284
• MDR Text Key: 76195709
• Report Number: 0001822565-2017-03657
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2018

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 Catalogue Number: 00585001201
• Device Lot Number: 63112815
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/30/2017
• Supplement Dates Manufacturer Received: 07/13/2017; 01/10/2018
• Supplement Dates FDA Received: 08/10/2017; 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Weight: 50