MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION (TM) ADM TRIAL INS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 1235-0-848

Device Problems Entrapment of Device (1212); Insufficient Information (3190)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 05/27/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device 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.

Event Description

Mdm insert trial (28/48/42e 1235-0-848) was left in patient from primary surgery and discovered by dr.(b)(6) during revision.

Manufacturer Narrative

An event regarding user error involving an adm trial insert was reported.The event was confirmed.Method & results: -device evaluation and results: a review of the provided photograph nothing visually remarkable about the device.The device was not returned for analysis.-medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated, - malfunction of the device is not in question, it concerns a trial device that functioned properly but had to be removed before the end of arthroplasty surgery.This pi case is not device-related.Procedure-related factors: - trial device left in patient after end of arthroplasty procedure.Patient-related factors: - none.Device-related factors: - none.Diagnosis: - a trial device was left in the patient after the end of surgical procedure and was discovered and removed during a subsequent revision surgery.-device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies -complaint history review: a review of the complaint history database shows that there have been no similar reported events for the subject lot code.Conclusions: a review by clinical consultant concluded: - malfunction of the device is not in question, it concerns a trial device that functioned properly but had to be removed before the end of arthroplasty surgery.This case is not device-related.No further investigation for this event is required at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Mdm insert trial (28/48/42e 1235-0-848) was left in patient from primary surgery and discovered by dr.(b)(6) during revision.

• Brand Name: RESTORATION (TM) ADM TRIAL INS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6043184
• MDR Text Key: 57927109
• Report Number: 0002249697-2016-03295
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2016

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: 1235-0-848
• Device Lot Number: G3115428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2016
• Initial Date FDA Received: 10/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2016
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 86