MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC 133 T1 PPS HO; PROSTHESIS, HIP

Catalog Number 51-104110

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

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Burning Sensation (2146); Tingling (2171); Reaction (2414); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted.Once the investigation has been completed a follow-up mdr will be submitted.Concomitant medical products: part # 010000856/ liner / lot #6475495, part #110017102/ shell / lot #6428483, part #00625006530/bone screw/ lot #64356267, part # 650-1057/biolox head/ lot #2958839, part # 650-1065/trp sleve / lot #2950541.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01320, 0001825034-2020-01322, 0001825034-2020-01323.

Event Description

It was reported 3 months post implantation patient is allegedly experiencing hives, burning, swelling and pain into the thigh.Right hip remains implanted.The patient is going to have a metal allergy test conducted; however, no results have been provided to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: b4; b5; g4; g7; h2; h6.

Event Description

It was further reported the results of the metal patch allergy test were negative.However, patient is going to have further testing done for liner and cement components.The patient is now also alleging a tingling sensation.The patient¿s allergy doctor gave the patient additional steroids and another unknown medication to control the hives.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4:(b)(4).Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records progress notes, pathology and op notes identified approximately three weeks post implantation patient reported pain a level of zero ambulating with single crutch, discontinued walker, continuing exercises, and showing great improvements.One week later patient reported swelling at night, tightness and stiffness of right hip, no pain increase but increased stiffness in the morning that gets better, still ambulates with cane.The following week patient reported a little sore in the morning, tight painful to touch on top of incision feels hard, patient reports a decrease in tightness and pain post massage, incision healing well.Seven weeks post implantation patient stated walking with no assistive device, uses single crutch as needed, no pain, tightness in front of hip under incision, progressing well.Approximately 2 months¿ later patient was discharged from physical therapy.Patient reported soreness when on feet for most of the day, has been hiking 3-5 miles without difficulty, no longer uses crutch, completes adls without difficulty, has made significant progress overall with strength, arom, and functional activities, pain level 0, very satisfied, some difficulty with running but otherwise no difficulties.9 after surgery patient experienced burning sensation from top of the hip bone to middle of thigh; with movement, along the incision something not moving properly transition is not smooth with normal walking, pain along the incision - swelling right side of incision, pain top of the incision and top of hip bone pain level in the morning 4-5, in the evening pain level increases to a 10.Root cause was unable to 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 133 T1 PPS HO
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9899933
• MDR Text Key: 190007547
• Report Number: 0001825034-2020-01321
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 51-104110
• Device Lot Number: 6479649
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 04/17/2020; 06/26/2020
• Supplement Dates FDA Received: 05/07/2020; 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 62