MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SYSTEM ONE BIPOLAR; HIP IMPLANT

Catalog Number 6074-5022

Device Problems Contamination /Decontamination Problem (2895); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.The device was implanted, however part of the packaging was returned and is in the investigation process.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that, during a bha, a surgeon found a fragment of like a pet on the system-one.He removed it and implanted as is.

Event Description

It was reported that, during a bha, a surgeon found a fragment of like a pet on the system-one.He removed it and implanted as is.

Manufacturer Narrative

An event regarding foreign matter involving an other hip head was reported.The event was confirmed.Method & results: product evaluation and results: a visual inspection was conducted on the returned packaging.The inner and outer blister was returned along with the outer blister tyvek lid and the foreign material that was found inside of the inner blister packaging.The inner blisters retainer was not returned.Images of the retainer and the foreign material were provided.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the reported event ¿a surgeon found a fragment of like a pet on the system-one¿ was confirmed.According to nc investigation ¿per the complaint the fragment was removed from within the inner blister assembly, the fragment material was identified through ftir testing and confirmed that the fragment was petg material which likely came from a defective or damaged retainer within the packaging assembly which ensures that the product and packaging assembly remain biocompatible.¿ this device was implanted during surgery.

• Brand Name: SYSTEM ONE BIPOLAR
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7936130
• MDR Text Key: 123677184
• Report Number: 0002249697-2018-03213
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 6074-5022
• Device Lot Number: TN5TT1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other