MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC MICRO LAT FMRL 12.5MM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Impaired Healing (2378)

Event Date 07/21/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biolox ceramic modular head ,catalog 12-115130, lot 179430; mallory head ringloc shell, 58mm catalog 11-104058, lot 947600; e-poly maxrom acetabular liner size 25, catalog ep-106885, lot 367240.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-07566, 0001825034-2018-07567, 0001825034-2018-07569, 0001825034-2018-07570.

Event Description

It was reported a patient underwent the first of a two-stage revision due to infection approximately four months post left total hip arthroplasty and then an i&d with placement of antibiotic beads four weeks later due to non-healing and drainage.Patient was re-implanted with permanent devices six weeks later during the stage ii procedure.

Manufacturer Narrative

Reported event was confirmed by review of op records provided.Op records of stage 1 revision stated that during procedure surgeon noted large subcutaneous fluid collection with purulence.Specimen was sent for culture/cell count, no results included.Fascia had dehisced and infection tracked through abductor repair & into joint space.Necrotic debris removed, stem and cup were noted well fixed and osteotomy was performed to remove stem.Op records of stage ii revision states that spacers were removed and permanent devices implanted.Device history record was reviewed and no discrepancies were found.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.

• Brand Name: TAPERLOC MICRO LAT FMRL 12.5MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7767401
• MDR Text Key: 116555956
• Report Number: 0001825034-2018-07566
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK062994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

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: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 15-103206
• Device Lot Number: 481770
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2018
• 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: 61 YR
• Patient Weight: 109