MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT DUAL GEOMETRY HA SHELL HIP IMPLANT

Catalog Number 2052-0050

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 05/25/2018

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. Not returned.

Event Description

Patient presented with pain. Dr. (b)(6) removed a loose acetabular component and femoral head. He then replaced with a tritanium cup and mdm construct.

Manufacturer Narrative

An event regarding revision due to loosening involving an omnifit 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 all devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the reported lot. 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

Patient presented with pain. Dr. Stewart removed a loose acetabular component and femoral head. He then replaced with a tritanium cup and mdm construct.

• Brand Name: OMNIFIT DUAL GEOMETRY HA SHELL
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7626747
• MDR Text Key: 111975742
• Report Number: 0002249697-2018-01920
• Device Sequence Number: 1
• Product Code: MEH
• 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

• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/1997
• Device Catalogue Number: 2052-0050
• Device Lot Number: 22877D
• 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: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/1992
• 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: 06/21/2018 Patient Sequence Number: 1