MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT HA PSL CUP/CLUSTR SHELL 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 2051-2048

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2021

Event Type  Injury  

Event Description

It was reported that the patient's right hip was revised due to dislocation of the head from the liner.The surgeon decided he wanted to reposition the shell, and to use a shell that could accommodate an mdm liner.Upon reduction, surgeon said the stem was too short for the construct, and revised the stem.The shell and stem (implanted approximately 20 years ago), and head and liner (implanted (b)(6) 2021) were revised.

Manufacturer Narrative

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

• Brand Name: SECUR-FIT HA PSL CUP/CLUSTR SHELL 48MM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13047942
• MDR Text Key: 286515955
• Report Number: 0002249697-2021-02072
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327020304
• UDI-Public: 07613327020304
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2021

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: 10/31/2002
• Device Model Number: 2051-2048
• Device Catalogue Number: 2051-2048
• Device Lot Number: PN3107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/1997
• 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; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 51 KG