MAUDE Adverse Event Report: ZIMMER BIOMET ORTHOPEDICS SELEX/MAGNUM MOD HD 40MM -6; PROSTHESIS, HIP

Catalog Number S061140

Device Problems Fitting Problem (2183); Device-Device Incompatibility (2919)

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

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was not confirmed.Product evaluation noted that the dimensional report showed the taper dimensions were conforming to print tolerances.Development and i were unable to determine root cause for why the head taper would not mate with the implant stem taper.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to 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.

Event Description

During the procedure, when the surgeon attempted to impact the head onto the stem, the taper did not match.It was reported that the outside label and the label that comes with the product indicated that it was a type i taper, which is compatible with the taper in the biometric stem.

• Brand Name: SELEX/MAGNUM MOD HD 40MM -6
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 7008750
• MDR Text Key: 92325128
• Report Number: 0001825034-2015-03776
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: S061140
• Device Lot Number: 063390
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2012
• 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