MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 36 0° X3 LINER; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Unstable (1667)

Patient Problems Pain (1994); Injury (2348)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that the patient's right hip was revised due to pain, instability, suspected loosening of the shell, and altr.Intra-operatively, corrosion on the trunnion and bone loss superiorly due to confirmed shell loosening were observed.No black tissue or trunnion wear were observed in the patient.The 56e shell, 36mm 0° x3 liner, and 36 +0 lfit v40 head were revised to stryker devices.The stem was noted well-fixed and well-positioned, the surgeon decided to clean off the trunnion and not revise the stem.

• Brand Name: UNKNOWN 36 0° X3 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: joanne mahony ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8190399
• MDR Text Key: 131184560
• Report Number: 0002249697-2018-04113
• Device Sequence Number: 1
• Product Code: KWA
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2018
• 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: 76 YR
• Patient Weight: 103