MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI LOW PROFILE SCREW 6.5X35MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Pain (1994); Post Operative Wound Infection (2446)

Event Date 11/26/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please also see associated report(s): 0001825034 - 2018 - 01094, 0001825034 - 2018 - 01095, 0001825034 - 2018 - 01096, 0001825034 - 2018 - 01098, 0001825034 - 2018 - 01099, 0001825034 - 2018 - 01100, 0001825034 - 2018 - 01102, 0001825034 - 2018 - 01103, 0001825034 - 2018 - 01104, 0001825034 - 2018 - 01105, 0001825034 - 2018 - 01106.Concomitant medical products: pm156856 higgins triflange 836820, 11-300918 arcos 18x190mm spl 251050, 163669 32mm mod head cocr 898680, 11-107004 r/c ii constrained 968020, 11-301310 arcos con sz a hi 650020, 103534 ti low profile screw 488910, 103534 ti low profile screw 998730 103535 ti low profile screw 998800, 103535 ti low profile screw 387710, 103533 ti low profile screw 980220, 103532 ti low profile screw 372110, 103532 ti low profile screw 364410.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a patient underwent right hip incision and debridement 21 days post-implantation due to wound drainage and pain.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.Reported event was confirmed by review of operative notes.The x-rays were received, but not reviewed as the complaint event is related to infection.Per the operative report, the patient was taken to surgery due to infection and pain.An incision and debridement was performed.No components were revised.There is no mention of osteomyelitis in the operative report.Dhr 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: TI LOW PROFILE SCREW 6.5X35MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7278927
• MDR Text Key: 100390940
• Report Number: 0001825034-2018-01107
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK082446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 103534
• Device Lot Number: 488910
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 65