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

Catalog Number UNK_REC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Swelling (2091)

Event Date 04/16/2012

Event Type  Injury  

Event Description

It was reported that in (b)(6) 2010, the patient had a torn meniscus, which required surgery, and the surgeon repaired the torn meniscus.After the surgery, the patient experienced some swelling for approximately a year.The patient consulted with another doctor who told him that he had no cartilage in his knee.On (b)(6) 2012, he underwent knee replacement surgery.Since the surgery, the patient has had sharp pains to his knee, which causes him to wake up in the middle of the night.He stated that he is able to walk for 5 to 6 miles, but he cannot bend his knee any further than a walking position as this is very painful.The patient has been on pain medication for approximately 2 years and stated that this is an inconvenience to him.

Manufacturer Narrative

No specific device information was provided.The only information noted that it was a right knee system.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device remains implanted.

• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4072139
• MDR Text Key: 4740404
• Report Number: 0002249697-2014-03429
• Device Sequence Number: 1
• Product Code: HRY
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2014
• 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): Other
• Patient Age: 68 YR
• Patient Weight: 95