MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH D-M 2.0MM BEADED CABLE SET VIT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6704-0-520

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 07/19/2019

Event Type  Injury  

Manufacturer Narrative

At this time, it cannot be determined which of the reported dall-miles cable devices broke however, an x-ray does show one broken cable.Since the catalog number for all of the reported cables are the same, the lot code for the cable has been reported as "unknown" and all of the reported cable lot codes are referenced below.Dall-miles beaded cable and sleeve set: cat# 6704-0-520, reported lot#'s 61355001; 60084202; 55777702; 51933201.It was noted that the device is not available for evaluation.If the broken cable lot number is later identified, or additional information becomes available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

A short 44 no 1 exeter stem was revised due to a periprosthetic fracture at the tip of the stem.The surgeon reported the stem had been implanted (b)(6) 2019 and a breach of the femoral cortex had occurred at the time of the surgery.This was treated with dall miles cables, but subsequently went on to fracture distal to the stem tip.Update: one cable was reportedly broken.

Manufacturer Narrative

An event regarding periprosthetic fracture involving a dall miles cable was reported.The event was confirmed by medical review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: the event description states, (b)(6) 2019 a breach of the femoral cortex at the time of surgery treated with dall-miles cable subsequently went on to fracture distal to the stem tip.¿ implant labels indicate four beaded dall-miles cable sets, a 58 tritanium hemispherical cluster shell, three screws, a restoration adm/mdm 28/42 x3 insert, a 48f mdm liner, a #1/44 exeter v-40 stem and a 28/0 v-40 head, and two units of palacos cement were utilized.On (b)(6) 2019 an inpatient note states, ¿left femur fracture sustained during fall, long standing osteopenia¿.On (b)(6) 2019 a revision of the left total hip arthroplasty was performed for which no operative report is available.A fracture of the distal femur at the stem tip was noted.Implant labels indicate a 19/195 restoration modular stem, a 25/0 v-40 restoration modular proximal femur, a 28/0 v-40 lfit head, a 28/52 x-3 insert for an adm/mdm, and two zimmer cable ready systems were utilized.X-ray printouts include an undated ap and lateral of the left hip and femur demonstrating a hybrid left total hip arthroplasty with two screws visible in the acetabulum with nominal position, reduced, and a displaced fracture of the femur at the tip of the stem and fracture of the cement mantel at that level is noted.Three dall-miles cables, two proximal to the fracture and one at the fracture site with that cable being broken, are noted.Osteopenia is noted.In this elderly, osteopenic woman, revision of a cemented hemiarthroplasty after fourteen years in situ was complicated by an intraoperative breach of the femoral cortex, which was managed by a prophylactic dall-miles cable.Two months later after a fall she sustained a periprosthetic fracture distal to the stem tip, which was treated with a long-stem modular revision femoral component.There is no evidence this clinical picture was related to factors of implant design, manufacturing or materials.No examination of explanted components is available.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the med review confirmed 'left femur fracture sustained during fall, long standing osteopenia' and 'there is no evidence this clinical picture was related to factors of implant design, manufacturing or materials.' no further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

A short 44 no 1 exeter stem was revised due to a periprosthetic fracture at the tip of the stem.The surgeon reported the stem had been implanted (b)(6) 2019 and a breach of the femoral cortex had occurred at the time of the surgery.This was treated with dall miles cables, but subsequently went on to fracture distal to the stem tip.Update: one cable was reportedly broken.

• Brand Name: D-M 2.0MM BEADED CABLE SET VIT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8897149
• MDR Text Key: 154731991
• Report Number: 0002249697-2019-02861
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07613327036466
• UDI-Public: 07613327036466
• Combination Product (y/n): N
• PMA/PMN Number: K953818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 6704-0-520
• Device Lot Number: 61355001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 89