MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/+2,5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 6570-0-536

Device Problems Break (1069); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems Inflammation (1932); Pain (1994); Toxicity (2333); Injury (2348); Reaction (2414)

Event Date 04/25/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Sales rep reported a left primary hip revision due to possible metallosis and pain.During surgery, visual cue showed a black mark and damage to trunnion and head.Component is well fixed.Rep stated surgeon implanted a mix of stryker and competitor devices for revision.

Manufacturer Narrative

Additional information: brand name; product code; common device name; catalog; returned to manufacturer on; pma/510(k).The actual lot # for the reported device is unknown at this time, however one of the following is the possible lot number involved in the reported event: 27161801, 26949202, 26949201, 26971702, 26971701, 26720201, 26601602, 26601601.An event regarding pain involving a ceramic head was reported.The event was not confirmed.Device evaluation and results: visual inspection: a visual inspection of the device by a material analysis engineer noted the following; metal transfer markings were observed on the head.A continuous metal transfer ring was observed at the proximal end of the stem, indicating proper seating between the trunnion and taper.A material analysis has been performed.The report concluded: burnishing, scratching and third-body indentation were observed on the insert.These are common damage modes of uhmpwe.Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: a review by a clinical consultant noted: of further relevance is that this patient had a biolox ceramic head while the stem was made of tmzf.For corrosion and pseudotumor formation, high levels of either cobalt and/or chrome are required but none of these materials is present in one of the arthroplasty devices.Titanium is not normally a cause for pseudotumor or corrosion related adverse local tissue reactions (altr).As such, it is highly unlikely that pseudotumor formation was the principal problem of this patient until proof of contrary with histopathology of retrieved tissue.The patient suffered from left anterior hip pain and muscle weakness while the fluid collections on mri were most predominantly located along the iliopsoas tendon.Both findings could be very well consistent with iliopsoas tendinitis with the iliopsoas tendon rubbing along the anterior margin of the acetabular component.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: a review by a clinical consultant concluded: such an underlying problem would be a more likely cause of the reported problems but would require an x-ray for verification of component (mal)position.Also more elaborate clinical findings might help solve this case that unfortunately cannot be completely solved due to especially adequate x-ray information.The reported failure mode by altr and pseudotumor is however very unlikely given the current findings.The exact cause of the event could not be determined because insufficient information was provided.A capa trend analysis was conducted for the reported failure mode and concluded pain may result from other factors not necessarily related to the device.No further investigation for this event is possible at this time if further information such as x-rays, patient history & follow-up notes become available this investigation will be reopened.

Event Description

Sales rep reported a left primary hip revision due to possible metallosis and pain.During surgery, visual cue showed a black mark and damage to trunnion and head.Component is well fixed.Rep stated surgeon implanted a mix of stryker and competitor devices for revision.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/+2,5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6583613
• MDR Text Key: 75716449
• Report Number: 0002249697-2017-01606
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

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 Catalogue Number: 6570-0-536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/22/2017
• Supplement Dates Manufacturer Received: 09/15/2017
• Supplement Dates FDA Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 75 YR
• Patient Weight: 55