MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC MICRO LAT FMRL 11MM; PROSTHESIS HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abscess (1690); No Code Available (3191)

Event Date 04/09/2008

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: item# 11-363660 36mm cocr mod hd -6mm lot# 505940; item # 11-104056 m/h sld/apx hle rnglc shl 56mm lot# 569300; item# ep-105914 epoly 36mm ringlc lnr hw sz24 lot# 974060.Customer has indicated that the product will not be returned to zimmer biomet for investigation as device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08027; 0001825034 - 2018 - 08026; 0001825034 - 2018 - 08025.

Event Description

It was reported a patient underwent primary left total hip arthroplasty approximately 10 years ago.Patient experienced distal wound separation and a small amount of seropurulent material on an unknown date.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).The follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes provided.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.The 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

It was reported that a patient underwent primary left total arthroplasty.Subsequently, the patient had distal wound separation and a small amount of seropurulent material and stitch abscess a month after the primary.

• Brand Name: TAPERLOC MICRO LAT FMRL 11MM
• 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: 7771139
• MDR Text Key: 116701399
• Report Number: 0001825034-2018-08024
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 15-103205
• Device Lot Number: 402250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 84