MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD CON DIST STEM 15 X 155 MM; IMPLANT

Catalog Number 6276-7-015

Device Problem Sticking (1597)

Patient Problem Unspecified Infection (1930)

Event Date 02/07/2014

Event Type  Injury  

Event Description

Removing restoration modular cone conical stem due to infection.A unitrax head was put on the stem.The thread from the distal stem extractor is stuck inside the stem, inside the patient.Therefore we were unable to replace the screw in the cone body.Surgeon plans to revise again when infection is cleared.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as a cone conical stem unknown size.An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Device not returned to the manufacturer.

Manufacturer Narrative

The patient is (b)(6) in height.An event regarding infection involving a restoration modular stem was reported.The event was confirmed.A review of the provided medical records and/or x-rays by a clinical consultant indicated: patient had mainly bad luck to belong to the small percent category of infectious arthroplasty complications.As such, the pi 432342 section root cause of failure is an adverse mix of patient-related and procedure-related factors.There are no device-related factors active in this case section and this pi 432342 case is not device-related.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 lot or sterile lot ids.Conclusions: medical review indicate root cause of failure is an adverse mix of patient-related and procedure-related factors.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.The following other devices were added to this report: 23mm mod rev hip bdy/blt +10mmcomponent level 9006-1-123; cat# 6276-1-123; lot# 36606401, trident 10° x3 insert 32mm id; cat# 623-10-32g; lot# 38221501, trident psl ha cluster 58mm; cat# 542-11-58g; lot# 31821301, 32mm +4 lfit v40 head; cat# 6260-9-232; lot# 37046706.It cannot be determined which, if any of these devices may have caused or contributed to the patient's infection.

Event Description

Removing restoration modular cone conical stem due to infection.A unitrax head was put on the stem.The thread from the distal stem extractor is stuck inside the stem, inside the patient.Therefore we were unable to replace the screw in the cone body.Surgeon plans to revise again when infection is cleared.

• Brand Name: MOD CON DIST STEM 15 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 NJ 07430 NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3667289
• MDR Text Key: 4197861
• Report Number: 0002249697-2014-00682
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/12/2014

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: 07/31/2016
• Device Catalogue Number: 6276-7-015
• Device Lot Number: CAXM111D
• Other Device ID Number: STERILE LOT# 1107ICM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 03/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2011
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 81