MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MD VIT SLV AND 2.0MM HOMOG CBL; BONE FIXATION CERCLAGE

Catalog Number 6704-0-510

Device Problems Degraded (1153); Loss of Osseointegration (2408)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 05/17/2023

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2016 and was revised on (b)(6) 2021.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.Update: per medical records received: pain, osteolysis, altr due to metallic wear debris, and bone deficiency around the stem were also reported.The head and liner were revised.The polyethylene liner was observed to have worn in a symmetric fashion.The dall-miles cable was removed and unneeded.It was loose and abrading the proximal portion of the stem slightly.Repair of the abductor muscle tear was performed as well as a bone graft and cement to address the thin cortical bone around the stem.The stem was well-fixed and not revised.The trunnion was in usable condition with mild visible burnishing and corrosion damage.

Manufacturer Narrative

Reported event: an event regarding loosening, altr, and wear/metallosis involving a dall-miles cable was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: "event confirmation: a primary total hip can be confirmed and was performed in 2016 with placement of a cobalt chrome head and tmz f stem and a dall-miles cable for a small fracture.A revision hip arthroplasty can be confirmed in 2021.Increased metal levels can be confirmed as reported in the operative note, laboratory results were not provided in a report.Metal response can be confirmed.Device fall and injury cannot be confirmed.Root cause: the root cause of the primary hip arthroplasty was osteoarthritis.The root cause of the revision was pain and a reported metal response.The cause of the mental response was reported to be trunnionosis but contribution from the dall-miles cable cannot be excluded.The root cause of the increased metal levels was likely a trunnion response." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to elevated cobalt and chromium levels and altr due to metallic wear debris.The dall-miles cable was removed and unneeded.It was loose and abrading the proximal portion of the stem slightly.A review of the provided medical records by a clinical consultant indicated: "event confirmation: a primary total hip can be confirmed and was performed in 2016 with placement of a cobalt chrome head and tmz f stem and a dall-miles cable for a small fracture.A revision hip arthroplasty can be confirmed in 2021.Increased metal levels can be confirmed as reported in the operative note, laboratory results were not provided in a report.Metal response can be confirmed.Device fall and injury cannot be confirmed.Root cause: the root cause of the primary hip arthroplasty was osteoarthritis.The root cause of the revision was pain and a reported metal response.The cause of the mental response was reported to be trunnionosis but contribution from the dall-miles cable cannot be excluded.The root cause of the increased metal levels was likely a trunnion response." 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 through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2016 and was revised on (b)(6) 2021.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.Update: per medical records received: pain, osteolysis, altr due to metallic wear debris, and bone deficiency around the stem were also reported.The head and liner were revised.The polyethylene liner was observed to have worn in a symmetric fashion.The dall-miles cable was removed and unneeded.It was loose and abrading the proximal portion of the stem slightly.Repair of the abductor muscle tear was performed as well as a bone graft and cement to address the thin cortical bone around the stem.The stem was well-fixed and not revised.The trunnion was in usable condition with mild visible burnishing and corrosion damage.

• Brand Name: MD VIT SLV AND 2.0MM HOMOG CBL
• Type of Device: BONE FIXATION CERCLAGE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18533019
• MDR Text Key: 333087404
• Report Number: 0002249697-2024-00101
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 6704-0-510
• Device Lot Number: 53451212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2015
• 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: 70 YR
• Patient Sex: Female