MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS 23CM DIAPHYSEAL SEGMENT; PROSTHESIS, KNEE

Catalog Number 150474

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdrs were submitted for this event.Please see reports: 0001825034 - 2019 - 02924, 0001825034 - 2019 - 02925.Item number 150474, lot number 358290, item name oss 23cm diaphyseal segment, (b)(4).Item number 150474, lot number 190220, item name oss 23cm diaphyseal segment, (b)(4).Item number 151842, lot number 558140, item name oss 13cm tapered diaph segment, (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified.No patient or surgical involvement.No further information available at this time.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported packaging damage event was confirmed via visual examination.It was identified the packaging was damaged in transit.Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.Root cause is attributed to transit damage.These products were likely conforming when they left zimmer biomet control.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: OSS 23CM DIAPHYSEAL SEGMENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8773084
• MDR Text Key: 151152078
• Report Number: 0001825034-2019-02923
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K123501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2024
• Device Catalogue Number: 150474
• Device Lot Number: 358290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1