MAUDE Adverse Event Report: STRYKER CORPORATION INSTRUMENTS SHOULDER INFUSION PAIN PUMP; PUMP, INFUSION, ELASTOMERIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arthritis (1723); Pain (1994); Disability (2371)

Event Date 11/11/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, i was diagnosed with pagcl - post arthroscopic glenohumeral chondrolysis as a result of a stryker corporation pain pump being inserted directly into my shoulder joint during arthroscopic surgery to repair a torn labrum.Since the diagnosis, i have had 2 add'l shoulder surgeries and require a full shoulder replacement.I was informed by an orthopedic surgeon that the stryker corp shoulder pain pump completely destroyed the cartilage in my shoulder.I have had several mri's and x-rays to confirm the complete loss of cartilage, and advanced osteoarthritis.I have also had physiotherapy, pain specialist treatment, narcotics, injections, osteopathic treatment, chiropractor treatment.The disability has taken a severe physical, emotional, and financial toll on my life.The pain pump was inserted intra-articularly for 72 hours following surgery to dispense bupivacaine.The stryker corp shoulder pain pump was never approved by the fda for use directly inside the shoulder joint, however stryker corp markets the product as safe according to my orthopedic surgeon's office.The pain pump was inserted into my shoulder joint during an arthroscopic surgery by(b)(6) when i was a young high school student.(b)(6) did not inform me about the pain pump causing my loss of cartilage and pagcl diagnosis until more than two years after the surgery.(b)(6) statute of limitation laws for defective medical devices requires a lawsuit to be filed within 2 years after the injury.Therefore, all of the attorneys that i have contacted have informed me that they are unable to help me because statute of limitations have expired, even though i did not learn about the dangers of the pain pump causing my condition until years later.When victims of the stryker corp shoulder pain pump do not discover the source of their injury until statute of limitations has expired, they are unable to seek justice.I would encourage the fda to issue new and strong warnings against the use of shoulder pain pumps in order to warn the public and bring attention to the issue for state and federal legislators to enact laws that protect pt victims suffering with pagcl as a result of the stryker corporation shoulder pain pump.Multiple shoulder surgeries, loss of shoulder cartilage, pagcl diagnosis, osteoarthritis, loss of shoulder function, chronic irreversible pain.

• Brand Name: SHOULDER INFUSION PAIN PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): STRYKER CORPORATION INSTRUMENTS
• MDR Report Key: 8790716
• MDR Text Key: 151287541
• Report Number: MW5088105
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: LU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/29/2019

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 30 YR
• Patient Weight: 82