MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 46OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	71322046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision was performed due to painful right hip bipolar arthroplasty with erosive changes of the acetabulum.Taper femoral head, shell/ uhmwpe liner and femoral component were exchanged and procedure was converted to a total hip replacement.Stem was retained.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the root cause of the ¿erosion¿ of the acetabular region cannot be definitively concluded and it cannot be ruled out that progression of disease played a role and therefore not a failure of a smith and nephew device.Without x-rays or the explanted components a full investigation cannot be made.The activity of the patient is unknown and the prosthesis was insitu about eleven years.A review of the complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness or wear.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.

• Brand Name: TANDEM BIPOLAR COCR 46OD 28ID
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10551840
• Report Number: 1020279-2020-04658
• Device Sequence Number: 3538258
• Product Code: KWY
• UDI-Device Identifier: 03596010492456
• UDI-Public: 03596010492456
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 71322046
• Device Catalogue Number: 71322046
• Device Lot Number: 07BM07767
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention