MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZMR TAPER STEM LGE JNCT.22X185; HIP PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unk, hip femoral head, unk liner, unk cup, unknown zmr body.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 by the patient¿s legal counsel that the patient underwent hip arthroplasty.Legal counsel further reports patient underwent a revision procedure due to patient allegations of pain, bone tissue damage, and implant fracture.Attempts have been made, and no further information is available.

Event Description

It was reported the patient underwent hip revision due to pain, implant fracture, bone fracture and abscess/infection.The patient was treated with a complete removal of left total hip arthroplasty with placement of antibiotic spacer, orif left distal femur shaft fracture with plate and screw and excisional debridement of left lower thigh abscess.Attempts have been made, and no further information is available.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of medical record review.Review of the device history record identified no deviations or anomalies that would contribute to the reported event.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: ZMR TAPER STEM LGE JNCT.22X185
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7204180
• MDR Text Key: 97712380
• Report Number: 0001822565-2018-00290
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: PK992667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00998202218
• Device Lot Number: 60806802
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 01/18/2018
• Supplement Dates Manufacturer Received: 05/22/2018; 10/04/2018
• Supplement Dates FDA Received: 06/19/2018; 10/11/2018
• Removal/Correction Number: Z-0323-2012
• Patient Sequence Number: 1
• Treatment: 00620205820 / 60778310 CUP; 00625006520 / 60854360 SCREW; 00625006525 / 60861067 SCREW; 00625006530 / 60829639 SCREW; 00625006530 / 60854337 SCREW; 00630505836 / 60794885 LINER; 00801803605 / 60156813 HEAD; 00999001940 / 60045979 BODY
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR