MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PCA ACE/LOW PROFILE SHELL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6289-5-058

Device Problems Degraded (1153); Device Slipped (1584); Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 02/22/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Right total hip, osteolysis of acetabulum / no medial wall, loosened cup / well fixed stem.Replaced with restoration cup ii acetabular shell and x3 insert cemented.

Manufacturer Narrative

An event regarding loosening involving a pca shell was reported.The event was confirmed.Method and results: device evaluation and results: visual inspection was performed as part of the material analysis report and indicated the evidence of biological matter was observed on the beaded fixation surface of the acetabular shell.No material or manufacturing defects were observed on the device features evaluated.Medical records received and evaluation: a review of the provided medical records by a clinical consultant concluded: "a routine adverse event related to the wear particles generated from tha in place for 27 years.This is a well-known phenomenon, believed to be related to the polyethylene wear particles, which cause bone resorption, and subsequent loosening of the prosthesis.She has significant osteolysis about the left total hip and that prostheses is also at risk for failure.This adverse event is the result of normal wear into polyethylene and there is no evidence that the loose right acetabulum is causally related to the design, manufacture, or defective material of this prosthesis.-device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: the clinician review of the medical records indicated a routine adverse event related to the wear particles generated from tha in place for 27 years.This is a well-known phenomenon, believed to be related to the polyethylene wear particles, which cause bone resorption, and subsequent loosening of the prosthesis.There is no evidence that the failure is related to the design, manufacture, or defective material of this prosthesis.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.

Event Description

Right total hip, osteolysis of acetabulum / no medial wall, loosened cup / well fixed stem.Replaced with restoration cup ii acetabular shell and x3 insert cemented.

• Brand Name: PCA ACE/LOW PROFILE SHELL 58MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5504006
• MDR Text Key: 40429180
• Report Number: 0002249697-2016-00839
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K853886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2016

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: 01/30/1994
• Device Catalogue Number: 6289-5-058
• Device Lot Number: RLUJA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/1989
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR