MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; INSTRUMENT

Catalog Number UNK_REC

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 10/15/2014

Event Type  malfunction  

Event Description

Patient was revised on left hip due to loosening.Zimmer product was taken out.During the surgery the 2.13mm distal reamer broke, doctor went up to 15mm to complete the surgery with no delay.

Manufacturer Narrative

Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Not returned to manufacturer.

Manufacturer Narrative

An event regarding alleged crack/fracture involving a 2.13mm distal reamer the event was not confirmed.Method and results: device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation.Medical records received and evaluation: no patient medical records were available for review.Device history review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.

Event Description

Patient was revised on left hip due to loosening.Zimmer product was taken out.During the surgery the 2.13mm distal reamer broke, doctor went up to 15mm to complete the surgery with no delay.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4225253
• MDR Text Key: 4994269
• Report Number: 0002249697-2014-04179
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other