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

Catalog Number UNK_REC

Device Problems Component Falling (1105); Malposition of Device (2616); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/13/2014

Event Type  Injury  

Event Description

It was reported that patient had primary right total hip surgery on (b)(6) 2014.As per sales rep, the surgeon closed the patient up and cup was malpositioned.On (b)(6), patient had to be revised for dislocation.During the revision surgery, while the surgeon was drilling the screws into the cup, 3 drillbits fell off into the patient.The surgeon retrieved two of them and closed the patient up with one drillbit left in.After surgery, when patient was x-rayed, the drillbit was discovered floating around in the patient's body.Sales rep indicated that she and the scrub tech checked the drill shafts before surgery and they worked fine.

Manufacturer Narrative

The catalog number is unknown at this time.Device description reported as unknown tritanium cup.An evaluation of the device cannot be performed as the device was not returned due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report.Not returned to manufacturer.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: IMPLANT
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4322439
• MDR Text Key: 16987378
• Report Number: 0002249697-2014-04601
• Device Sequence Number: 1
• Product Code: JDI
• 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
• Report Date: 11/13/2014

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 Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 12/11/2014
• 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): Required Intervention
• Patient Age: 27 YR