MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/H 3HOLE RLC SHL NRS 46MM/L22; PROSTHESIS HIP

Model Number N/A

Device Problems Fracture (1260); Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2018

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.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

It was reported when implant was taken out of box it was found broken and in poor condition.No patient harm.No additional information.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of photographs which indicated damage to locking ring.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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.

Event Description

It was reported that when implant was taken out of box, it was found broken and in poor condition.Further information received, noted that the locking ring was noted to be damaged when the cup was being prepared.No patient harm.No additional information.

• Brand Name: M/H 3HOLE RLC SHL NRS 46MM/L22
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7923098
• MDR Text Key: 122310946
• Report Number: 0001825034-2018-08795
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

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 Model Number: N/A
• Device Catalogue Number: 13-104146
• Device Lot Number: 791040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1