MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM REVISION ACETABULAR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 509-02-56E

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned.

Event Description

The patient presented with aseptic loosening of the acetabular cup, which was revised in (b)(6) 2018.The femoral stem was left in place during the first revision.The cup loosened again, requiring a second revision.When we exposed the components, we noticed that the mdm liner/acetabular shell wore a notch into the neck of the femoral stem.We removed all components and inserted a restoration modular stem, multihole acetabular cup and constrained liner.

• Brand Name: TRITANIUM REVISION ACETABULAR
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8518012
• MDR Text Key: 142049413
• Report Number: 0002249697-2019-01617
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327025156
• UDI-Public: 07613327025156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• 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
• Report Date: 04/16/2019

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: 07/31/2023
• Device Catalogue Number: 509-02-56E
• Device Lot Number: 41421M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR