MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN FEM HEAD MEMPHIS CERAMIC; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKNOWN

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Injury (2348); Arthralgia (2355)

Event Date 12/05/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patient's left hip due to pain in and around her left hip joint, squeaking, limp, and sleep interruption.The patient outcome is unknown.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the revision operative report noted ¿a significant amount of yellowish fibrinous type material in between the metal liner and shell.¿ however, the implantation report noted a 32 mm ceramic hip ball, 48 mm r3 shell with a ceramic insert were initially implanted.The clinical root cause of the pain and squeaking cannot be confirmed; the extensive fibrinous type scar tissue and neutral orientation of the acetabular cup cannot be ruled out as contributing factors of the reported event.It cannot be concluded the reported events were associated with a mal performance of the implant.The patient impact beyond the revision cannot confirmed; however, it is noted, the patient experienced 2 dislocations post revision.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, alignment, size selected and/or wear.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.

Event Description

It was reported that, after a ceramic-on-ceramic thr construct had been implanted on the patient¿s left hip on (b)(6) 2011, the patient experienced pain, squeaking and stiffness associated to the left hip.A revision surgery was conducted on (b)(6) 2018 to treat this adverse event.During this procedure, the ceramic femoral head and liner were explanted and replaced with a bearing combination that consisted of a smith and nephew xlpe liner and oxinium head.The patient¿s outcome is unknown.

Manufacturer Narrative

H11: report number updated from 3005975929-2020-00259 to 1020279-2020-00259.

• Brand Name: UNKN FEM HEAD MEMPHIS CERAMIC
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; spa park; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; spa park; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; spa park; austin, TX 78735 ; 5123913905
• MDR Report Key: 10312917
• MDR Text Key: 200018003
• Report Number: 3005975929-2020-00259
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female