MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS COCR PRI SO 12/14 SZ 0; PROSTHESIS, HIP, SMI-CONSTRAINED, MTAL/POLYMER, CEMENTD

Model Number	71312360
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a thr procedure, the patient has undergone recurrent dislocations due to soft tissue laxity.For this reason, revision surgery was performed and the stem was removed to gain access to the acetabulum (stem was well fixed, well-positioned) and replaced with a same-sized stem.All explanted implants have been discarded.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation, and the reported event could not be confirmed.A review of the device history records for the reported batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Although there were no prior complaints for three of the four reported devices.A clinical analysis indicated that it was reported that after a thr procedure on (b)(6) 2018, the patient has undergone recurrent dislocations due to soft tissue laxity.For this reason, revision surgery was performed on (b)(6) 2020 and the stem was removed to gain access to the acetabulum (stem was well fixed, well-positioned) and replaced with a same-sized stem.All explanted implants have been discarded.No medical imaging or clinical documentation has been provided to confirm the recurrent dislocations.Without supporting medical documentation, a thorough medical assessment cannot be performed.In the event additional medical / clinical records are received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.The risk management file and instructions of use for the product were reviewed.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.Based on this investigation, the need for corrective action is not indicated.If new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.Be re-opened.We consider this investigation closed.

• Brand Name: CPCS COCR PRI SO 12/14 SZ 0
• Common Device Name: PROSTHESIS, HIP, SMI-CONSTRAINED, MTAL/POLYMER, CEMENTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9788320
• Report Number: 1020279-2020-00779
• Device Sequence Number: 2778268
• Product Code: JDI
• UDI-Device Identifier: 03596010461995
• UDI-Public: 03596010461995
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K970351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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 Model Number: 71312360
• Device Catalogue Number: 71312360
• Device Lot Number: 18HM00974
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1