MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX MODULAR ENDO HEAD 48MM; IMPLANT

Catalog Number 6942-5-048

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 02/02/2015

Event Type  Injury  

Event Description

It was reported that patient had a hemi arthroplasty (b)(6) 2007, since then patient has been dislocating off and one over the last 8 years, pt finally opted to have a revision, pt came to surgery, opened pt in normal fashion for a hip revision, doctor dissected down to the hip joint, removes unipolar and sleeve with a metal tamp, under the sleeve and on the trunion was amino r amount of metallosis, nothing that the doctor thought was a concern, noticed pt's acetabulum was shallow and could not ream a high hip center, he opted to use zimmer tantalum.Cup and acetabulum augment, once final preparation for augment was done the implant was placed into final position, final cup and liner implanted, a trial c-taper head was trailed to doctors satisfaction and good range of motion with no dislocation the final head was implanted, pt was closed in normal fashion and left surgery in satisfactory condition.

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, the evaluation summary will be submitted in a supplemental report.

Manufacturer Narrative

No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information become available, this investigation will be reopened.

Event Description

It was reported that patient had a hemi arthroplasty (b)(6)2007, since then patient has been dislocating off and one over the last 8 years, pt finally opted to have a revision, pt came to surgery, opened pt in normal fashion for a hip revision, doctor dissected down to the hip joint, removes unipolar and sleeve with a metal tamp, under the sleeve and on the trunion was aminor amount of metalosis, nothing that the doctor thought was a concern, noticed pt's acetabulum was shallow and could not ream a high hip center, he opted to use zimmer tantalum.Cup and acetabulum augment, once final preparation for augment was done the implant was placed into final position, final cup and liner implanted, a trial c-taper head was trailed to doctors satisfaction and good range of motion with no dislocation the final head was implanted, pt was closed in normal fashion and left surgery in satisfactory condition.

• Brand Name: UNITRAX MODULAR ENDO HEAD 48MM
• 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: 4551495
• MDR Text Key: 5527264
• Report Number: 0002249697-2015-00491
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014226
• 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: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Catalogue Number: 6942-5-048
• Device Lot Number: A07K450
• Other Device ID Number: STERILE LOT MSH0707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2007
• 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: 87 YR
• Patient Weight: 63