MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY; SCP KIT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2019, the patient underwent the initial subchondroplasty procedure with the preoperative diagnosis of hip femoroacetabular impingement, hip labral tear, loose body in hip, and acetabular subchondral fracture.A left hip arthroscopy with acetabuloplasty, hip arthroscopy with labral repair, hip arthroscopy with femoroplasty, hip arthroscopy with loose body removal, and left hip percutaneous fixation of acetabular stress fracture were concomitantly performed.There were no intraoperative complications reported during the index surgery.On (b)(6) 2019, at 12 weeks and 1 day postoperatively, the patient complained of a popping in their hip and that the pain was described as a 4/10 with soreness and pinching.The event was reported as possibly related to the procedure and possibly related to the device.In an effort to be conservative, this complaint will be treated as a serious injury and will be investigated further.There was no indication of swelling, discoloration, or deformity of the left hip.The patient indicated that the pain resumed after they returned to work, stopped taking naproxen, and resumed teaching aerobics.The patient was guided to resume taking naproxen and ibuprofen.Zimmer knee creations was notified of the issue on (b)(6) 2019.The product was not returned for the investigation, as it remains implanted in the patient.The dhr for the finished goods lot was reviewed, and no anomalies related to the complaint condition were noted.
Event or Problem Description
Subject (b)(6) had left hip pain as adverse event after subchondroplasty.
Event or Problem Description
Subject 02-001 had left hip pain as adverse event.
Additional Manufacturer Narrative
On (b)(6)2019, subject 02-001 underwent a subchondroplasty, percutaneous fixation of an acetabular stress fracture, as well as labral repair, acetabuloplasty, femoroplasty, and loose body removal in an arthroscopic procedure of the left hip.It was reported that 3cc of accufill were injected into the left acetabulum in zone 2 and 3l.There were no intraoperative complications reported.The operative notes for the index procedure and the clinical notes for the 12-week follow-up appointment were reviewed as a part of the investigation.On (b)(6) 2019, at the 12-week post-operative follow-up appointment conducted as a part of the clinical study, subject 02-001 had the main complaint of popping in the hip joint, and it was reported that the patient is doing better in comparison to the last visit.The subject also reported pain during activity (pain was rated a 4 out of 10), denied numbness or tingling and is fully weight bearing and going to physical therapy once a week.There was no swelling, discoloration or deformity of the left hip, and the patient experienced mild limitation of range of motion in the left hip.It was noted in the clinical notes that the adverse event outcome was determined to be recovering/resolved, and the patient will resume naproxen, ibuprofen, and physical therapy.It is unlikely that the popping of the joint is related to the subchondroplasty procedure as the fixation was internal in the acetabulum and joint popping is normally related to the joint surface and ligamentous structures.There is no clear indication that the pain reported is directly related to the subchondroplasty procedure, and at 12 weeks, patients are normally still in the recovery process.The exact cause of the adverse event cannot be determined at this time, but it most likely due to the proximity of the event to the surgical date.The dhr for the raw material and finished goods lot was reviewed, and no anomalies related to the complaint condition were noted.The product was not returned for the investigation, as it remains implanted in the patient.

• Brand Name: SUBCHONDROPLASTY
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9495244
• Report Number: 3008812173-2019-00054
• Device Sequence Number: 13974716
• Product Code: OJH
• UDI-Device Identifier: 00889024205260
• UDI-Public: 00889024205260
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 402.202
• Device Lot Number: KC04875
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/22/2019
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN 308.041,LN 34857.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Weight: 69