MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN CONSTRAINED POLY LINER; HIP IMPLANT

Catalog Number UNK_JR

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problems Inflammation (1932); Discomfort (2330); Injury (2348); Reaction (2414)

Event Date 05/01/2009

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

An operative report from (b)(6) 2009 indicated a revision procedure from an implant date of 2002.As reported in the justification: "has developed mechanical failure and discomfort associated with her left total hip.Has developed mechanical noises and grinding sensation with activity which has become progressive.Her preoperative workup revealed fracturing of the containment ring.Of this constrained insert.Evidence of luxation of the bipolar ball".Evidence of metallosis and tissue discoloration and a chipped screw was reported intra-operatively.All components except the stem were explanted.Patient was revised to a tritanium hemispherical shell with screws, x3 poly insert, and an lfit c-taper metal head with a c-taper adapter sleeve.

• Brand Name: UNKNOWN CONSTRAINED POLY LINER
• Type of Device: HIP 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: bradley curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7565971
• MDR Text Key: 109949360
• Report Number: 0002249697-2018-01682
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 61