MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT HA HIP STEM #6; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number 6017-0625A

Device Problems Degraded (1153); Material Deformation (2976)

Patient Problems Erosion (1750); Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 07/09/2008

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

It was reported that:"it was reported through the attorney for the patient, as a result of a lawsuit, that allegedly the patient received a trident ceramic on ceramic hip system.It was further alleged that, the patient began to experience some difficulties, requiring a revision surgery on august 6, 2008." update as per medical review: "on (b)(6) 2008 a revision of the right total hip was performed with removal of loose, fractured ceramic pieces.Extensive metallosis was noted and a revision total hip was performed for a diagnosis of fractured ceramic head and liner, displaced metal liner, erosion superior acetabular shell, and extensive wear debris.".

Manufacturer Narrative

An event regarding wear involving an omnifit 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 revealed: ¿on (b)(6), 2008 a revision of the right total hip was performed with removal of loose, fractured ceramic pieces.Extensive metallosis was noted and a revision total hip was performed for a diagnosis of fractured ceramic head and liner, displaced metal liner, erosion superior acetabular shell, and extensive wear debris.¿ [¿] ¿among the findings in the report were, "trunnion scored and worn, superior acetabular shell has a hole worn through, two of the three screws had the heads eroded off, prompt surgery suggested but patient delayed¿.[¿] ¿x-ray printouts related to the right hip include a series dated (b)(6) 2008, which is an ap of the pelvis demonstrating a right uncemented total hip arthroplasty with the trunnion without a head with multiple radiodense fragments distal to the acetabulum and lateral to the hip.The trunnion is dislocated proximally.Two screws are visible and the acetabular shell appears more vertical than nominal.The metal-backed alumina insert appears to be disassociated.X-ray dated (b)(6), 2008 is an ap of the pelvis demonstrating further disassociation of the acetabular insert and fragmentation.¿ [¿] ¿no readable post-operative x-ray of the primary right total hip arthroplasty prior to the (b)(6), 2008 post head fracture films to allow for evaluation of the initial acetabular position and seating of the alumina insert are available for review.In a ceramic/ceramic bearing a vertical acetabular position can contribute to mechanical failure.Delay in revision surgery from the time of the diagnosis of the ceramic bearing failure on (b)(6) 2008 until surgery on (b)(6) 2008 with the patient remaining active was largely responsible for the excessive fragmentation, metallosis, and diffuse distribution of the particular debris.There is nothing unique in the stryker products compared to competitive ceramic/ceramic bearings that contributed to the complications in this case which were increased by delay in revision surgery.Based upon the information available for review, no determination can be made regarding the cause of the initial fracture of the ceramic bearing four years after implantation in this case.¿ - 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 medical review indicated, ¿delay in revision surgery from the time of the diagnosis of the ceramic bearing failure on july 9, 2008 until surgery on august 6, 2008 with the patient remaining active was largely responsible for the excessive fragmentation, metallosis, and diffuse distribution of the particular debris.¿ the investigation confirmed that the stem was worn with a potential root cause of the excessive fragmentation and delay in revision surgery.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.

Event Description

It was reported that:"it was reported through the attorney for the patient, as a result of a lawsuit, that allegedly the patient received a trident ceramic on ceramic hip system.It was further alleged that, the patient began to experience some difficulties, requiring a revision surgery on (b)(6) 2008." update as per medical review: "on (b)(6) 2008 a revision of the right total hip was performed with removal of loose, fractured ceramic pieces.Extensive metallosis was noted and a revision total hip was performed for a diagnosis of fractured ceramic head and liner, displaced metal liner, erosion superior acetabular shell, and extensive wear debris.".

• Brand Name: OMNIFIT HA HIP STEM #6
• 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
• MDR Report Key: 7900659
• MDR Text Key: 121438302
• Report Number: 0002249697-2018-03005
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07613327038248
• UDI-Public: 07613327038248
• Combination Product (y/n): N
• PMA/PMN Number: K982032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2006
• Device Catalogue Number: 6017-0625A
• Device Lot Number: 63472401
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 76