MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH REST HA -5 RED NK 155MM STRT STM 8X12MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number S-2651-0812

Device Problem Mechanical Problem (1384)

Patient Problems Hematoma (1884); Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)

Event Date 11/13/2012

Event Type  Injury  

Manufacturer Narrative

An event regarding impingement and metallosis involving a restoration stem was reported.The event was confirmed by medical review.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant concluded: ¿on (b)(6) 2011 her tests were negative for infection and she had no pain at that time.On (b)(6) 2012 she noted "pain for five months.Told hematoma returned".Mri showed "possible metallosis".Physical examination revealed mild pain on rotation of the left hip.X-ray showed good alignment and no wear or loosening bilaterally.The plan was bearing revision.On (b)(6) 2012 a revision of the left total hip arthroplasty to change the liner and head was performed for a diagnosis of painful left total hip arthroplasty." [.] ".At surgery an impingement of the titanium neck on the acetabular rim with metallosis in the joint and anterior cyst "likely due to metallosis" was noted.The bearing was changed to a 32/10° poly and a 32/0 cobalt-chromium head.Uncomplicated surgery was described and the patient was subsequently discharged home on (b)(6) 2012.¿ [¿] ¿no examination of the explanted ceramic-ceramic bearing and no surgical pathology report are available.Metallosis as described from impingement of the neck of the femoral component on the metallic rim of the ceramic acetabular insert was the result of version of either the femoral and/or acetabular components and not related to factors of prosthetic design, manufacturing, or materials.The clinical situation was apparently resolved by changing the bearing to metal-poly components at revision surgery on (b)(6) 2012." product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the metallosis was caused by the impingement between the metallic rim of the ceramic insert on the neck of the femoral component.The clinician indicated that the possible root cause for the version of either the femoral and/or acetabular components, however the x-ray images provided reveal that the images are in nominal position.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.Device not returned.

Event Description

"on (b)(6) 2012 she noted "pain for five months.Told hematoma returned".Mri showed "possible metallosis".[.] during the left hip revision surgery, "at surgery an impingement of the titanium neck on the acetabular rim with metallosis in the joint and anterior cyst "likely due to metallosis" was noted." update 17-jan-2019: medical review clarified that tritanium neck impinged on the metal rim of the ceramic insert.

• Brand Name: REST HA -5 RED NK 155MM STRT STM 8X12MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8269044
• MDR Text Key: 133826519
• Report Number: 0002249697-2019-00268
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07613327019315
• UDI-Public: 07613327019315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2019

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: 10/31/2008
• Device Catalogue Number: S-2651-0812
• Device Lot Number: 95369101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2003
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 45