MAUDE Adverse Event Report: ZIMMER BIOMET, INC. IMPACTOR FOR USE WITH 48 MM I.D. CUP; HIP INSTRUMENTATION

Model Number N/A

Device Problems Crack (1135); Metal Shedding Debris (1804)

Patient Problem No Patient Involvement (2645)

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 during inspection, the impactor was found cracked and it had metal debris embedded in its surface.The instrument was not used in the surgery and no harm to any patient was noted.No other additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: it was identified an internal software error produced and submitted an invalid 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

Complaint sample was evaluated and the reported event was confirmed.Visual inspection confirmed the impactor surface to have multiple cracks and metallic debris imbedded.Device history record (dhr) was reviewed and no discrepancies were found.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: IMPACTOR FOR USE WITH 48 MM I.D. CUP
• Type of Device: HIP INSTRUMENTATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7566581
• MDR Text Key: 109994905
• Report Number: 0001822565-2018-02942
• 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: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2018

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: 00151603048
• Device Lot Number: 62614044
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 06/12/2018; 12/12/2018
• Supplement Dates FDA Received: 06/13/2018; 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1