MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GEN.II SECUR-FIT (AD,HA) SHELL PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number 543-11-52E

Device Problem Loss of Osseointegration (2408)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 11/08/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding loosening involving a securefit shell was reported. The event was not confirmed. Device evaluation and results: not performed as product was not returned medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: could not be performed as lot code information is invalid. Complaint history review: could not be performed as lot code information is invalid. The exact cause of the event could not be determined because insufficient information was provided. Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event. If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

This pi will address the revision surgery relating to the loose cup. It was reported that revision surgery of cup and head was done at (b)(6) 2018. The +10 metal head was implanted after the cup was revised. Update (b)(6) 2018: cup was done and then they decided to implant the head at the same time. But the heads was bigger than it was supposed to be as per protocol.

• Brand Name: GEN.II SECUR-FIT (AD,HA) SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8153100
• MDR Text Key: 130019584
• Report Number: 0002249697-2018-03996
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K983382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 543-11-52E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/13/2018
• 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 Treatment Data

Date Received: 12/11/2018 Patient Sequence Number: 1