MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SYS 12 26MM 10D DURATN INS P4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6302-5-044

Device Problem Naturally Worn (2988)

Patient Problems Injury (2348); Insufficient Information (4580)

Event Date 05/20/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

For pi - revision of a vitalock liner implanted in 2003 for poly wear.During procedure surgeon was satisfied that the femur and acetabulum were well fixed after 17 years, therefore replaced only the liner and exeter head.The opportunity was taken to increase the head size to 32mm ( from 26mm).Case went smoothly.Surgeon was very pleased with the performance of the implant.He said the patient was extremely active and only around 60 years old when he had his thr.Note- there is no other information available, and the surgeon had no complaint with the device.

Manufacturer Narrative

Reported event: an event regarding wear involving duratn insert 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 by a clinical consultant indicated: implant labels:56 vitalock cluster shell, 2 screws, 26/10 degree poly insert, #2 exeter stem, 26/std femoral head, exeter bone plug, antibiotic simplex bone cement.Color photo of explanted, blood stained, intact metallic modular head and poly insert.2/26/03 brief op note right tha diagnosis oa right hip uncomplicated surgery hybrid exeter tha.12/10/19 x-rays ap pelvis , lat.Right hip: bilateral hybrid tha reduced, nominal,.Right hip approximately 4 mm acetabular poly wear noted.No clinical or pmh, no revision surgery operative report, no examination of explanted components.Based upon the x-rays, confirmation of poly wear noted in the event description is made, but the indication for the revision surgery after 17 years in situ is not clarified.Insufficient data is available to create a medical report for this case.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there has been no other similar events for the reported lot.Conclusion: a review of the provided medical records by a clinical consultant indicated: implant labels: no clinical or pmh, no revision surgery operative report, no examination of explanted components.Based upon the x-rays, confirmation of poly wear noted in the event description is made, but the indication for the revision surgery after 17 years in situ is not clarified.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

For pi - revision of a vitalock liner implanted in 2003 for poly wear.During procedure surgeon was satisfied that the femur and acetabulum were well fixed after 17 years, therefore replaced only the liner and exeter head.The opportunity was taken to increase the head size to 32mm ( from 26mm).Case went smoothly.Surgeon was very pleased with the performance of the implant.He said the patient was extremely active and only around 60 years old when he had his thr.*note- there is no other information available, and the surgeon had no complaint with the device.

• Brand Name: SYS 12 26MM 10D DURATN INS P4
• 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: 10151161
• MDR Text Key: 195091923
• Report Number: 0002249697-2020-01167
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K993352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2007
• Device Catalogue Number: 6302-5-044
• Device Lot Number: 04381901
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 90