MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM REVISION ACETABULAR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 509-02-54E

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Injury (2348); Hip Fracture (2349)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.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 similar events for the lot referenced.Should additional information become available it will be reported in a supplemental report.

Event Description

Patient slipped and fell.The patient sustained a further fractured pelvis and resulted in the patient requiring additional surgery.This was to revise the plate and cup in the right hip replacement.The implants that had formed the initial pi 2019030 were explanted.The 1/3rd tubular plate that was initially implanted for the posterior column fracture was revised and a matta pelvic plate applied.The cup was removed along with the screws.The shaft of the 40mm gap cup screw ( item 20800040 lot pw17h7) was broken with the fall.Screw head and part of the shaft came out; the distal part of the shaft dr ellis elected to leave in situ.The fracture of the superior pelvic ramus; that had been observed during review of the post-op x-rays from the initial revision on 18th of february was still visible.The t-mars (zimmer) revision cup that was put in today, had a screw hole; which went along the trajectory of the superior pubic ramus.No further fixation was applied to this fracture; no further plates or screws.No further medical records are available due to confidentiality.The explanted implants were discarded by the nursing staff and unable to be retrieved.

Event Description

Patient slipped and fell.The patient sustained a further fractured pelvis and resulted in the patient requiring additional surgery.This was to revise the plate and cup in the right hip replacement.The implants that had formed the initial pi 2019030 were explanted.The 1/3rd tubular plate that was initially implanted for the posterior column fracture was revised and a matta pelvic plate applied.The cup was removed along with the screws.The shaft of the 40mm gap cup screw ( item 20800040 lot pw17h7) was broken with the fall.Screw head and part of the shaft came out; the distal part of the shaft dr ellis elected to leave in situ.The fracture of the superior pelvic ramus; that had been observed during review of the post-op x-rays from the initial revision on 18th of february was still visible.The t-mars (zimmer) revision cup that was put in today, had a screw hole; which went along the trajectory of the superior pubic ramus.No further fixation was applied to this fracture; no further plates or screws.No further medical records are available due to confidentiality.The explanted implants were discarded by the nursing staff and unable to be retrieved.

Manufacturer Narrative

Additional information: patient information.An event regarding periprosthetic fracture involving a trident shell was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted shell.The shell is covered in biological matter and there is evidence of boney ingrowth.There is no evidence of damage to the device from the photos provided.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: event description states: ".Patient fell.Fractured pelvis.Revision plate and cup right hip replacement.1/3 tubular plate initially implanted for posterior column fracture.Revised.Pelvic plate applied.Cup removed.Shaft of gap cup screw.Broken.Fracture of superior pelvic ramps.Noted post-op 18 feb.Still visible.Competitor revision cup put in today." x-ray print-outs @ ap pelvis 1 lat.Right hip all undated bilateral uncemented tha with both acetabular reconstructions - left with broken hook of cage - right with multiple plates and screws and acetabular component protrusion into pelvis.3 unlabeled photos of explanted acetabulum.Cup, screws, metal head, poly and metal inserts.2 implant sheets with multiple implant labels of competitor components and 1 stryker 28/12 lfit head.No clinical or pmh, no op reports, no exam of explanted components.Based upon the information available for review, no medical report is possible, or confirmation of the event description is possible." device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been one other similar event for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRITANIUM REVISION ACETABULAR
• 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: 9625541
• MDR Text Key: 188641479
• Report Number: 0002249697-2020-00154
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327025149
• UDI-Public: 07613327025149
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• 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: 02/28/2020

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 Expiration Date: 07/31/2018
• Device Model Number: 509-02-54E
• Device Catalogue Number: 509-02-54E
• Device Lot Number: JV70X6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR