MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +8 V40 TAPER VIT HEAD; IMPLANT

Catalog Number 6260-5-332

Device Problems Device Dislodged or Dislocated (2923); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 11/10/2014

Event Type  Injury  

Event Description

Patient had a hip replaced with the meridian femoral and osteolok cup in 2002 by dr (b)(6).Patient complained of a dislocating hip (anterior) in the past months.Dr (b)(6) revised the hip for dislocation.Upon exposure, it showed some " black tar" around the head taper function.Upon further examination, the trunnion has slightly worn flat portion on the superior aspect of the taper.Dr (b)(6).Elected to revise the stem.He performed a trochanteric osteotome and removed the stem.Restoration modular was used to replace and the liner was revised.The old liner showed no wear but had some oxidation.He revised the liner as well.

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.Device not returned to manufacturer.

Manufacturer Narrative

Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events reported for the reported manufacturing lot medical review: regarding the referenced pi, this case represents a male patient whose date of birth is (b)(6), and who is described as (b)(6) inches tall, weighing (b)(4) pounds.On (b)(6) 2002 he underwent a primary right total hip arthroplasty for a diagnosis of osteoarthritis of the right hip.An operative report describes general anesthesia and a posterolateral approach.The acetabulum was reamed to (b)(4), after which autografting of a superior acetabular cyst was described.The components implanted included a vitalock #60 cluster shell with two screws, a 32/10° crossfire insert, a #5/13 meridian stem, and a 32/plus-8 v-40 vitallium head.Uncomplicated surgery was described.On (b)(6) 2014 a revision of the right total hip with a poly exchange, change of the stem, and a trochanteric osteotomy was performed for a post-operative diagnosis of linear wear, periacetabular cyst, and severe metal arthrosis.The operative report notes, "multiple surgeries" recurrent dislocations - large bulging greenish mass posterior to greater trochanter - abundant green cloudy fluid and debris - cup not loose, stem loss of bone around calcar - tremendous - corrosive wear at head/stem interface noted.Inside head - decided to revise stem - with burr and osteotomes, therefore requiring extended trochanteric osteotomy.The stem was changed to a restoration modular 155/17 stem.A 27/0 proximal body, a 32/10° plus-4 lateralized liner, and a 32/0 biolox v-40 ceramic head were utilized, and uncomplicated surgery was described.The use of four dall-miles cable sets for trochanteric repair was noted.X-ray copies available for review include an undated ap and lateral of the right hip demonstrating an uncemented primary right total hip arthroplasty with one long screw visualized in the acetabulum.The hip is reduced and components are in nominal position with no evidence of loosening, wear or osteolysis noted.No clinical or past medical history, no examination of the explanted components, no histopathology report from the revision surgery, and no operative reports of "multiple surgeries for recurrent dislocations" are available.Some corrosion products noted within the modular head junction is not unexpected after twelve years in situ in this large male patient.The "periarticular cyst" noted in the post-operative diagnosis of the revision operative report may represent the cyst noted at the primary surgery in 2002, which was autograft.More clinical information, examination of the explanted components, and histopathology are required to evaluate this case.The effect of the "multiple previous surgeries" and serial x-rays are also critical to evaluating this case.There is no evidence this late clinical complication was the result of factors of faulty component design, manufacturing, or materials.The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

Patient had a hip replaced with the meridian femoral and osteolok cup in 2002 by dr (b)(6) in (b)(6).Patient complained of a dislocating hip (anterior) in the past months.Dr (b)(6) revised the hip for dislocation.Upon exposure it showed some "black tar" around the head taper function.Upon further examination the trunnion has slightly worn flat portion on the superior aspect of the taper.Dr (b)(6).Elected to revise the stem.He performed a trochanteric osteotome and removed the stem.Restoration modular was used to replace and the liner was revised.The old liner showed no wear but had some oxidation.He revised the liner as well.

• Brand Name: 32MM +8 V40 TAPER VIT HEAD
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4309786
• MDR Text Key: 5207461
• Report Number: 0002249697-2014-04547
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2014

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: 12/31/2006
• Device Catalogue Number: 6260-5-332
• Device Lot Number: 7246642
• Other Device ID Number: STERILE LOT 01338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 12/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2001
• 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: 67 YR
• Patient Weight: 106