MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN OSTEONICS STEM IMPLANTED 2002 HIP IMPLANT

Catalog Number UNK_JR

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Injury (2348); Ambulation Difficulties (2544); Inadequate Osseointegration (2646)

Event Date 05/09/2018

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.

Event Description

It was reported that the patient's left hip was revised due to a loose stem. Examination notes provided by the rep state: "on (b)(6) [2017] a near slip and fall on her wet kitchen floor with both legs going in all sorts of different directions. She was unable to walk afterwards. Reports now pain in the deep posterior right hip area. The pain in the deep buttocks is somewhat sharp and episodic. " the stem (implanted in 2002), adapter sleeve, head, and insert (all implanted (b)(6) 2009) were revised to an exeter cemented stem with biolox ceramic head, adm/mdm construct, and additional screw.

• Brand Name: UNKNOWN OSTEONICS STEM IMPLANTED 2002
• 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: 7565333
• MDR Text Key: 109923110
• Report Number: 0002249697-2018-01676
• Device Sequence Number: 1
• Product Code: JDL
• 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
• 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?: No

Device Operator

• Device Catalogue Number: UNK_JR
• 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: 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 Treatment Data

Date Received: 06/04/2018 Patient Sequence Number: 1