MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD CON DIST STEM 17 X 155 MM; IMPLANT

Catalog Number 6276-7-017

Device Problem Failure to Disconnect (2541)

Patient Problem No Code Available (3191)

Event Date 06/03/2014

Event Type  Injury  

Event Description

Explantation of a restoration modular: cone conical after infection.Ingrowth of the implant had taken place, so it was not possible to disconnect the body from the stem without preparing the implant site.The intention was to disconnect the body from the stem when the site of the was fully prepared and then use an open drill to remove the stem.But unfortunately it was not possible to disconnect the body from the stem, although the body was fully exposed and not connected to bone anymore.The instruments were used properly and several attempts were made.Because they were not able to disconnect the body from the stem, they could not drill the stem out so they had to open the femur.It was a 195mm stem, so a large part of the femur had to be opened.Eventually they removed the stem and replaced a new cone conical with dall-miles cables.

Manufacturer Narrative

The patient is (b)(6) centimeters in height.An event regarding infection involving a restoration modular stem was reported.The event was not confirmed.Visual inspection indicated the stem showed signs of ingrowth and in vivo use.Device history review: records indicate the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported sterile lot or lot ids.Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of bloodwork for infection were not provided.A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.

Event Description

Explantation of a restoration modular: cone conical after infection.Ingrowth of the implant had taken place, so it was not possible to disconnect the body from the stem without preparing the implant site.The intention was to disconnect the body from the stem when the site of the was fully prepared and then use an open drill to remove the stem.But unfortunately it was not possible to disconnect the body from the stem, although the body was fully exposed and not connected to bone anymore.The instruments were used properly and several attempts were made.Because they were not able to disconnect the body from the stem, they could not drill the stem out so they had to open the femur.It was a 195mm stem, so a large part of the femur had to be opened.Eventually they removed the stem and replaced a new cone conical with dall miles cables.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported as an unknown 6267-7- mod con dist stem.A supplemental report will be submitted upon completion of the investigation.

• Brand Name: MOD CON DIST STEM 17 X 155 MM
• 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: 3895112
• MDR Text Key: 18366322
• Report Number: 0002249697-2014-02430
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K022549
• 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: 06/03/2014

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: 06/30/2017
• Device Catalogue Number: 6276-7-017
• Device Lot Number: CAXN221C
• Other Device ID Number: STERILE LOT: 1206CCM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 06/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/02/2014
• 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: 58 YR
• Patient Weight: 55