MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH P4 32MM 15DEG INSERT OSTEOLOCK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 5260-4-595

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

Patient Problems Injury (2348); No Code Available (3191)

Event Date 09/21/2015

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.Not returned to manufacturer.

Event Description

It was reported that surgeon revised patient's right hip due to poly wear.Surgeon replaced poly and head only.All other components were well fixed.

Manufacturer Narrative

An event regarding wear involving a osteolock liner was reported.The event was not confirmed.Method & results: -device evaluation and results: no devices were available for analysis.-medical records received and evaluation: no patient medical records were available for review.-device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there have been no other events for the reported lot.Conclusions the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.However, wear is expected after approximately 20 years of in vivo use, based off of the manufacture date of the device.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that surgeon revised patient's right hip due to poly wear.Surgeon replaced poly and head only.All other components were well fixed.

• Brand Name: P4 32MM 15DEG 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: 5151251
• MDR Text Key: 28305513
• Report Number: 0002249697-2015-03388
• 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: Followup
• Report Date: 09/21/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/1997
• Device Catalogue Number: 5260-4-595
• Device Lot Number: TWSFA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/1992
• 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: 90 YR
• Patient Weight: 67