MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SUPER SECURE FIT STEM; HIP IMPLANT

Catalog Number UNK_SHC

Device Problems Corroded (1131); Degraded (1153); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problems Injury (2348); Joint Dislocation (2374); No Code Available (3191)

Event Date 12/29/2015

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device remained implanted.

Event Description

Revision for recurrent dislocation.It was reported that suspicion of corrosion was confirmed around the head internal and neck of stem.The surgeon implanted the new head after cleaning surrounding the neck to avoid removal of the stem.

Manufacturer Narrative

An event regarding corrosion involving an unknown securfit stem was reported.The events were confirmed.Method and results: device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.However material analysis was performed on the returned metal head.Sem/eds analysis of the metal head indicated the presence of cr and mo peaks and no co peak, consistent with the presence of corrosion products.The ti peak is consistent with material transfer from the stem.Medical records received and evaluation: a review by a clinical consultant concluded that high cup position with low hip offset contribute to instability in the arthroplasty leading to recurrent dislocation requiring revision.The corrosion findings are secondary to overload as caused by the instability.Conclusions: a review by a clinical consultant concluded that high cup position with low hip offset contribute to instability in the arthroplasty leading to recurrent dislocation requiring revision.The corrosion findings are secondary to overload as caused by the instability.If further additional information and/or device become available, this investigation will be reopened.

Event Description

Revision for recurrent dislocation.It was reported that suspicion of corrosion was confirmed around the head internal and neck of stem.The surgeon implanted the new head after cleaning surrounding the neck to avoid removal of the stem.

• Brand Name: SUPER SECURE FIT STEM
• Type of Device: HIP 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5389337
• MDR Text Key: 36804138
• Report Number: 0002249697-2016-00181
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• 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: 12/29/2015

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: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2015
• Initial Date FDA Received: 01/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2016
• 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: 64 YR
• Patient Weight: 56