MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT

Catalog Number UNK_REC

Device Problem Crack (1135)

Patient Problem No Code Available (3191)

Event Date 10/06/2014

Event Type  Injury  

Event Description

Revision surgery on hip due to cracked liner.

Manufacturer Narrative

Catalog number is unknown at this time.The device was reported as an unknown cup.Additional information has been requested and if received, will be provided in the supplemental report.Not returned.

Manufacturer Narrative

An event regarding loosening involving an unknown shell was reported.The event was confirmed.-medical records received and evaluation: a review of the provided information by a clinical consultant confirmed shell loosening but could not determine a root cause.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including return of device, operative reports, more x-rays, patient history, progress notes is needed to fully investigate the event.

Event Description

Revision surgery on hip due to cracked liner.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4221368
• MDR Text Key: 4977329
• Report Number: 0002249697-2014-04093
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2014

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 Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2014
• Initial Date FDA Received: 11/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/23/2014
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 87