MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH D/M 8.0 IN SS BROAD COMP PLATE; PLATE, FIXATION, BONE

Catalog Number 3704-3-110

Device Problems Break (1069); Fracture (1260)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Injury (2348)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

Biomedical engineer from the hospital reported the following event: "moderate slip in the bathroom.Thigh deformity appeared.Impotence and disability.Partial fracture of the plate found on x-ray on (b)(6) 2018.Change of material on (b)(6) 2018.".

Event Description

Biomedical engineer from the hospital reported the following event: "moderate slip in the bathroom.Thigh deformity appeared.Impotence and disability.Partial fracture of the plate found on x-ray on (b)(6) 2018.Change of material on (b)(6) 2018.".

Manufacturer Narrative

An event regarding a periprosthetic fracture and crack/fracture involving a dall miles plate was reported.The periprosthetic fracture was confirmed following a clinician review.The plate crack/fracture was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: a review of the provided medical record by a clinical consultant indicated: a traumatic fall of the patient through slip in the bathroom caused a periprosthetic hip fracture requiring open reduction and internal stabilization of the fracture using a dall-miles plate with cartilage cables after removal of an older dm-plate that had been used for stabilization of a femoral access osteotomy in a previous hip revision surgery for femoral stem loosening.Satisfactory final result.-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 or sterile lot.Conclusion: the plate crack/fracture was not confirmed.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available and/or the product is returned, this investigation will be re-opened.

• Brand Name: D/M 8.0 IN SS BROAD COMP PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7703097
• MDR Text Key: 114454208
• Report Number: 0002249697-2018-02224
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327036633
• UDI-Public: 07613327036633
• Combination Product (y/n): N
• PMA/PMN Number: K922525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 3704-3-110
• Device Lot Number: 56919401
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR