MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC 133 FEMORAL PRIMARY TYPE1 POROUS PLASMA SPRAY STANDARD OFFSET 6.0; HIP PROSTHESIS

Model Number N/A

Device Problem Flaked (1246)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: biomet rnglc+ ltd hole fin shl sz52 item#: 16-104152, lot#: 319050, biomet arcomxl 32mm rlc lnr hw sz23 item#: xl-105923, lot#: 426300, biomet 32mm mod head cocr -3mm neck item#: 163668, lot#: 515360, biomet flexible silicone drill driver item#: 110010733, lot#: 440930.

Event Description

It was reported that during total hip arthroplasty, the porous coat on the stem began flaking.Pieces fell into patient and were removed prior to the closure of the incision.Stem was still implanted into patient.No additional patient consequences were reported.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.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.A summary of the investigation has been sent to the complainant.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: TAPERLOC 133 FEMORAL PRIMARY TYPE1 POROUS PLASMA SPRAY STANDARD OFFSET 6.0
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7475482
• MDR Text Key: 106976332
• Report Number: 0001825034-2018-02844
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK103755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 51-100060
• Device Lot Number: 3840309
• Other Device ID Number: 00880304498174
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR