MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26X52-55MM 10 DEG HOOD INS; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)

Catalog Number 6283-5-525

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Injury (2348)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

Pca cup and liner revised due to poly wear.Patient had described pain in their right hip.Cup and liner discarded and unable to be returned.

Manufacturer Narrative

An event regarding wear involving a pca liner was reported.The event was confirmed by medical review and examination of photograph provided.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: there is a significant amount of biological material on all surfaces of the device.There is also some wear on the outer rim of the device.There is nothing else of note visible from the photos provided.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: patient had a pressfit pca total hip implanted in 1997.An undated ap pelvis x-ray was reviewed which demonstrates eccentric position of the femoral head within the acetabulum.This is indicative of polyethylene liner wear.On (b)(6) 2019 this tha was revised due to this wear.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the medical review concluded the following: review of these records confirm a revision tha for polyethylene wear in a pressfit pca occurred 22 years after implantation.Volumetric wear in a polyethylene liner of this vintage is not unexpected.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

Pca cup and liner revised due to poly wear.Patient had described pain in their right hip.Cup and liner discarded and unable to be returned.

• Brand Name: 26X52-55MM 10 DEG HOOD INS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8495443
• MDR Text Key: 141330344
• Report Number: 0002249697-2019-01567
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• PMA/PMN Number: K921384
• 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: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/1997
• Device Catalogue Number: 6283-5-525
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR