MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CUP IMPACTOR; HIP INSTUMENTATION

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problem No Information (3190)

Event Date 03/15/2018

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)(6).

Event Description

It was reported that debris appearing to be metallic formed inside the white area of the impactor tip.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

It was identified an internal software error produced and submitted an invalid d2 device product code in the previous submissions related to this reporting.The device product code has been updated with no further changes.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 information available.

Manufacturer Narrative

Device was returned to the manufacturer for evaluation.As returned the cup impactor exhibited wear & tear to the connecting features.The device has metal particles embedded on the dome.Dimensional measurements are conforming to print specifications.Device history record (dhr) was reviewed and no discrepancies were found.The issue of metal debris in the impactor was previously investigated through capa (b)(4).The capa resulted in updating the dfmea as well as a surgical technique.However, a definite root cause cannot be determined.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: CUP IMPACTOR
• Type of Device: HIP INSTUMENTATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7414680
• MDR Text Key: 105286157
• Report Number: 0001822565-2018-02070
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00151603044
• Device Lot Number: 63675189
• Other Device ID Number: (01) 00889024434073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 06/04/2018; 12/10/2018
• Supplement Dates FDA Received: 06/05/2018; 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1