MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_2-MM DALL MILES CABLE

Catalog Number UNK_SHC

Device Problem Degraded (1153)

Patient Problems Inflammation (1932); Pain (1994); Reaction (2414)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding pain and high cobalt levels involving a dall miles cable was reported.The event was confirmed through review of the provided medical records.Method & results: device evaluation and results: the reported device was not returned however an intra-operative photograph of the dall miles cable was provided for review.The photograph shows clearly shows the proximal dm-cable is very ¿shiny¿, or ¿polished¿ in-situ wrapped around the proximal part of the femur.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: movement between a dm-cable and underlying soft tissues has gradually but persistently contributed to local metallic debris generation with local tissue metallosis and elevated blood cobalt levels requiring revision where femoral head and liner were exchanged with no complete information available about this second hip revision surgery to allow to further detail the findings.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the reported device was not returned however photographs were provided for review.An intra-operative photograph of the dall miles cable was provided for review.The photograph shows clearly shows the proximal dm-cable is very ¿shiny¿, or ¿polished¿ in-situ wrapped around the proximal part of the femur.Review of the medical records by a clinician has indicated that movement between a dm-cable and underlying soft tissues has gradually but persistently contributed to local metallic debris generation with local tissue metallosis and elevated blood cobalt levels requiring revision where femoral head and liner were exchanged with no complete information available about this second hip revision surgery to allow to further detail the findings.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Device not returned.

Event Description

As reported: "patient was brought in for a hip revision.Patient was having pain and high cobalt levels indicated metallosis per [surgeon].Explanted head and liner but retained stem.Metal debris and soft tissue damage noted, damage to trunnion of stem but didn't warrant pulling implant.[surgeon] had to debride soft tissue and repair to the best of his ability.Replaced head and liner".Patient was revised to a 36 +5 biolox head and sleeve and 36e liner.Update from medical review: movement between a dm-cable and underlying soft tissues has gradually but persistently contributed to local metallic debris generation with local tissue metallosis and elevated blood cobalt levels requiring revision.

• Brand Name: UNKNOWN_2-MM DALL MILES CABLE
• Type of Device: UNKNOWN
• 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: joanne mahony ; ida industrial estate; carrigtwohill NA ; 214532800
• MDR Report Key: 8568436
• MDR Text Key: 143670887
• Report Number: 0002249697-2019-01776
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 78 YR