MAUDE Adverse Event Report: ARTHROSURFACE, INC. 2.5MM GWIRE 2MM SHT GUID PINS AND TP; PIN, FIXATION, SMOOTH

Lot Number 75BH1335

Device Problems Loose or Intermittent Connection (1371); Nonstandard Device (1420); Device Dislodged or Dislocated (2923)

Patient Problems Abscess (1690); Failure of Implant (1924); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 06/28/2018

Event Type  Injury  

Event Description

Response to: tell us what and how it happened.Please find docs and timeline listed below.Original surgery: partial shoulder replacement, (b)(6) 2018.Physical therapy begins within 2 weeks of surgery and lasts until late (b)(6) 2018.Had very good range of motion and strength with one exception: i could not sustain a direct load to shoulder.Condition appeared from the beginning and never improved; it is believed that this was the indicator that the glenoid component had dislodged very early on, within a month or less.Second surgery: (b)(6) 2018, to determine cause of drainage from suture line in shoulder; the previous incision was completely reopened and probed to the capsule.Several suture abscesses where forming by remaining vicryl suture that hadn't finished spitting.No evidence of sinus tract formation, deep space infection, or involvement of the joint capsule.Late (b)(6) 2018: topical abscess in suture line begins to form; visit dr (b)(6) twice in december before surgery on (b)(6).Dr confused as to why my condition persisted after the complete cleaning from previous surgery.Third surgery: (b)(6) 2018.No capsular infection/bacteria found; loose component detected.Dr (b)(6) at this time stated he believed the component had loosened due to bacteria breaking the bond of the cement to the bone and/or component.He said this process takes a long time to occur.Dr (b)(6) later agreed that no bacteria was found or cultured from the capsule and because there was no wear on the component a failure was possible.Fourth surgery: (b)(6) 2019; removal of loose prosthetic and implant of medicated space due to protocol for possible capsular infection.No infection/bacteria found.Infectious disease dr (b)(6) 2019; six weeks of twice a day anti-biotic infusion (90 min each) for suspected infection/bacteria.Never found or confirmed.Fifth surgery scheduled for (b)(6) 2019: reverse shoulder.After visiting with the four drs: (b)(6) - first surgeon, (b)(6) - physical therapist, (b)(6) - infectious decease, (b)(6) - second surgeon, the component was discovered loose less than 6 months after implantation, but after close review of the physical therapy documents by dr (b)(6).It was determined that the device had probably loosened soon after implantation.Because the arthrosurface 8156-0032 has already been the subject of a recall by the fda, i wanted to bring it to your attention.I do not have the financial ability to legally pursue this matter, but i was hoping by reporting it, i might help someone else.All - 0200s allogen xlarge, 2ml.On (b)(6) 2019: left shoulder allogen.

• Brand Name: 2.5MM GWIRE 2MM SHT GUID PINS AND TP
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHROSURFACE, INC.
• MDR Report Key: 8555740
• MDR Text Key: 143572469
• Report Number: MW5086208
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/05/2019
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/21/2023
• Device Lot Number: 75BH1335
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 62 YR
• Patient Weight: 89