MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26X46-49MM 10 DEG HOOD INS; IMPLANT

Catalog Number 6283-5-469

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

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

Event Date 07/23/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report.

Event Description

Patient follow up to surgeon's office shows extensive wear on the cup side.Cup was removed and a titanium revision cup was implanted with a pca head and constrained liner.Left hip.

Manufacturer Narrative

An event regarding worn cup was reported.Review of the medical records and x-ray by the clinician indicated a worn liner and a well fixed femoral and acetabular component.The event was confirmed.Method & results: -device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation.-medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated "in this large male patient, some poly wear of the acetabular insert is not unexpected twenty-five years after implantation.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this late clinical situation.-device history review: a review of the device history records could not be performed as no lot information was provided.-complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusion: the device wear and event of revision was confirmed.Clinician review of the medical records indicated some poly wear of the acetabular insert is not unexpected twenty-five years after implantation.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this late clinical situation.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

Patient follow up to surgeon's office shows extensive wear on the cup side.Cup was removed and a tritanium revision cup was implanted with a pca head and constrained liner.Left hip.Event update review of the medical records and x-ray by the clinician indicated a worn liner and a well fixed femoral and acetabular component.

• Brand Name: 26X46-49MM 10 DEG HOOD INS
• Type of Device: IMPLANT
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5013929
• MDR Text Key: 23430493
• Report Number: 0002249697-2015-02734
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K921384
• 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: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6283-5-469
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 66 YR
• Patient Weight: 99