MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ALL POLY CUP 28X43 NO POD; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71332843

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported that patient has a planned upcoming revision surgery due to fracture of the ceramic head of his hip.Tep inserted in 2005 with reflection cup and an unknown stem s&n ceramic inlay.

Manufacturer Narrative

It was reported that patient has a planned upcoming revision surgery due to fracture of the ceramic head of his hip.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device batch information was not made available, device history record review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.A review of the complaint history for the listed part revealed prior complaints for the listed failure mode.Per the complaint note, the device was implanted in 2005.Our investigation indicated that the device has been discontinued since 2009.Some potential causes of the reported event could include but are not limited to traumatic injury, lifetime of device or overuse.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

Manufacturer Narrative

Further review of this case indicates this is a duplicate report.The event in this report has been already reported under complaint number case-(b)(4).All further communication for this event will be managed in that case, including the final report with the results of our investigation.We respectfully request to close this case as a duplicate and refer to the referenced case above.

• Brand Name: ALL POLY CUP 28X43 NO POD
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• 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: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 10141016
• MDR Text Key: 194756916
• Report Number: 1020279-2020-02313
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 71332843
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 10/13/2020; 02/15/2022
• Supplement Dates FDA Received: 11/03/2020; 02/16/2022
• 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