MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN PSL SHELL 36MM; UNKNOWN HIP IMPLANT

Catalog Number UNK_JP

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Discomfort (2330); Injury (2348); Inadequate Osseointegration (2646)

Event Date 03/04/2010

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Additional information was received from legal on 7/6/2016 : patient reported that the right rejuvenate hip implanted on (b)(6) 2010 failed causing pain and elevated metal ion levels.Company representative reported on (b)(6) 2017, a revision of right hip of patient due to pain, discomfort and loosening of cup.

• Brand Name: UNKNOWN PSL SHELL 36MM
• Type of Device: UNKNOWN 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6649762
• MDR Text Key: 77844988
• Report Number: 0002249697-2017-01911
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2017
• 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: 56 YR
• Patient Weight: 145