MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH P6 32MM 10DEG INSERT OSTEOLOCK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 5260-4-570

Device Problems Degraded (1153); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problem 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.Went to patient.

Event Description

It was reported that 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

An event regarding osteolysis due to wear involving a p6 32mm 10deg insert osteolock 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 x-rays from the index and revision surgeries, outpatient office/clinic notes and implant retrieval." 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: clinician review of the provided information 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 information such as surgical implant records from the surgeries, pre and post op x-rays from the index and revision surgeries, outpatient office/clinic notes and implant retrieval are needed to complete the investigation for determining root cause.No further investigation is needed at this time.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that 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: P6 32MM 10DEG INSERT OSTEOLOCK
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5238610
• MDR Text Key: 31683070
• Report Number: 0002249697-2015-03949
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903362
• 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: 06/18/1997
• Device Catalogue Number: 5260-4-570
• Device Lot Number: TXMVA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/1992
• 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