MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LUQUE WIRE; WIRE, FIXATION

Model Number N/A

Device Problems Malposition of Device (2616); Noise, Audible (3273)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 09/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00660001722 porous fem st 17x153st rt lot# 56733400.Item #: unknown, unknown head, lot #: unknown.Item #: unknown , unknown cup , lot #: unknown.Item #: unknown , unknown liner, lot #: unknown.Item #: unknown , unknown luque wire, lot #: unknown x 6.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent an initial left hip arthroplasty.The patient underwent a revision surgery on eleven years post-implantation of unknown product due to aseptic loosening and metallosis.In order to revise the femoral stem, an extended trochanteric osteotomy was performed and luque wires were utilized for fixation.He later developed pain in the left hip.A year after the revision surgery, a luque wire was removed due pain with findings of bursitis over the greater trochanter and prominence of the wire.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, h2, h3, h6.Reported event was confirmed by review of medical records.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.Medical records identified a previous revision surgery in which an osteotomy was performed in order to remove femoral component.The site was secured with a figure 8 fashion luque wire.Patient developed pain over the greater trochanter on the left and had palpable popping and snapping over the lateral aspect of the hip in the region of the luque wire.Significant bursitis over greater trochanter.Removal of a prominent luque wire on the left hip without difficulty.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: UNKNOWN LUQUE WIRE
• Type of Device: WIRE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12300692
• MDR Text Key: 265967817
• Report Number: 0001822565-2021-02191
• Device Sequence Number: 1
• Product Code: DZK
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention