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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Necrosis (1971); No Code Available (3191)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

Patient (b)(6) experienced increased pain from left hip avascular necrosis after undergoing an initial subchondroplasty procedure on (b)(6) 2018.The 2 week, 6 week, 9 week, 12 week, and 9 month follow-up notes were received for the investigation.The patient was revised to a total hip on (b)(6) 2019.A dhr review cannot be completed as the lot number of the device in questions are unknown; the device cannot be returned for investigation since it remains implanted.As additional information about the event is reported, a supplemental report will be submitted with any additional findings.

Event Description

Clinical subject (b)(6) experienced pain from hip avascular necrosis after scp.

Manufacturer Narrative

The patient underwent scp on the right hip (b)(6) 2018.During the scp procedure, an intraportal capsulotomy was performed with extension medially and laterally.Additionally, a torn labrum and some loose bodies and synovitis were also noted.Mild extravasation was noted during the index procedure, and was addressed during the procedure.There were no major complications during the index procedure.Though earlier time points showed nature post op progression, patient presented at 9 months post op visit with continued pain and limp.Suspected femoral avn with conservative treatment was diagnosed at (b)(6) 2019 office visit.On (b)(6) 2019 the patient progressed to a tha.No further surgical interventions are currently identified.This complaint will be reopened if further surgical information is made available.The dhr was unable to be reviewed, as the lot number for the device related to the event was unable to be confirmed.The product was not returned for the investigation, as it remains implanted in the patient.

Event Description

Clinical subject (b)(6) experienced pain from hip avascular necrosis after scp.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8697899
• MDR Text Key: 147995783
• Report Number: 3008812173-2019-00032
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/14/2019
• Event Location: Hospital
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 105