MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM STANDARD FEMORAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6284-0-132

Device Problems Degraded (1153); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problems Pain (1994); Injury (2348); Osteolysis (2377)

Event Date 10/29/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available will be submitted in a supplemental report.

Event Description

The patient complained of right hip pain.Osteolysis was present.The poly insert and head were removed and replaced with new ones.The screws were also removed and filled with hydro set.

Manufacturer Narrative

Corrected data: an event regarding pain involving a pca head was reported.The event was confirmed.Method & results: device evaluation and results: could not be performed as no items associated with the event were returned for evaluation.Medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated "the primary harm involved is prosthetic wear.The prosthesis requiring revision has been implanted 20 years prior.This performance is within the expected parameters for this implant.Further documentation which would assist with a more complete assessment would include surgical implant records from the surgeries, pre and post op xrays from the index and revision surgeries, outpatient office/clinic notes and implant retrieval." device history review: all devices accepted into final stock conformed to specification.Complaint history review: not performed as no device specific failure mode was identified.Conclusions: clinician review of the provided information indicated the primary harm involved is prosthetic wear of the insert.It is unclear why the head was revised, however, it was reported that the patient was experiencing pain.No further investigation is possible at this time.Additional information such as surgical implant records from the surgeries, pre and post op xrays from the index and revision surgeries, outpatient office/clinic notes and implant retrieval are needed to complete the investigation for determining root cause.

Event Description

The patient complained of right hip pain.Osteolysis was present.The poly insert and head were removed and replaced with new ones.The screws were also removed and filled with hydro set.

• Brand Name: 32MM STANDARD FEMORAL HEAD
• 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: 5233624
• MDR Text Key: 31530354
• Report Number: 0002249697-2015-03880
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K831373
• 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: 10/29/2015

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: 12/31/1999
• Device Catalogue Number: 6284-0-132
• Device Lot Number: 9434803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/1994
• 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: 81 YR
• Patient Weight: 123