MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/H 3HOLE RLC SHL NRS 56MM/L24; PROSTHESIS - HIP

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

Product was returned and noted to have a small tear near one of the spikes on the shell.Reviewed product with packaging engineer and determined that the packaging bill of materials has been updated since the product was manufactured.The inner packaging used 01-97-6075c bag for the complaint product while the current bom uses 01-97-6055.The complaint has been confirmed that the product has a damaged bag.It cannot be determined what the root cause is, however, it is likely that this issue was caused by an extreme distribution event as the product has been recirculated in zb (b)(4) for 10 years.Review of the complaint history identified an additional complaint that was investigated, and it was determined that no further action is required due to the bill of materials has been updated to cover this issue.Review of device history records found these units were released to distribution with no deviations or anomalies.Completion of the investigation relayed to zimmer biomet (b)(4) via etq.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.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that upon receipt of the product on (b)(6) 2016, it was noticed that the inner sterile packaging was damaged during an inspection of recirculated product.

• Brand Name: M/H 3HOLE RLC SHL NRS 56MM/L24
• Type of Device: PROSTHESIS - HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7109823
• MDR Text Key: 95553053
• Report Number: 0001825034-2017-11103
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/12/2017

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: 05/28/2016
• Device Model Number: N/A
• Device Catalogue Number: 13-104156
• Device Lot Number: 503500
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1