MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT

Catalog Number UNK_REC

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384); Migration or Expulsion of Device (1395); Unintended Movement (3026)

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

Event Date 08/29/2014

Event Type  Injury  

Event Description

It was reported patient had revision of right knee due to migration of femoral stem and also loosening of the offset components.Doctor removed stem, femoral, distal augment, posterior augment and 28 mm insert.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown stem.An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Manufacturer Narrative

The event was confirmed by the provided medical records.Conclusions: the root cause of the reported femoral shaft fracture could not be determined with the information provided.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If the device and/or additional information become available, this investigation will be reopened.

Event Description

It was reported patient had revision of right knee due to migration of femoral stem and also loosening of the offset components.Doctor removed stem, femoral, distal augment, posterior augment and 28 mm insert.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4115898
• MDR Text Key: 4841116
• Report Number: 0002249697-2014-03597
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2015
• 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: 53 YR
• Patient Weight: 70