MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN SEL II POR HO 10/12 SZ 12; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 71305512

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Metal Related Pathology (4530)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Event Description

It was reported that, after tha surgery had been performed on (b)(6) 2010, the patient experienced pain and was diagnosed with pseudotumor on (b)(6) 2024.At the moment, no surgical intervention has been scheduled to treat this condition.Patient's current health status is unknown.

Manufacturer Narrative

The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, patient had a total hip arthroplasty in 2010 and reported pain and a pseudotumor.No revision has been scheduled at this time.Further clinical/ medical information was not provided; therefore, the clinical root cause of the pain and pseudotumor cannot be determined.The patient impact is the reported pain and pseudotumor.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: SYN SEL II POR HO 10/12 SZ 12
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18797855
• MDR Text Key: 336445391
• Report Number: 1020279-2024-00447
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 00885556018019
• UDI-Public: 885556018019
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71305512
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: REF XLP 28 20DEG/46-48D(PN:71333323,LN:UNK); RF INT ACET TH SZ48(PN:71336048); UN COCR10/12 TPR FM HD28MM(PN:1191,LN:UNK)