MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 28 +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71309011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Failure of Implant (1924); 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
B3 - corrected the date of event to 27sept2018 d10 - remove 71322046 07bm07767 as a concomitant device.
Event or Problem Description
It was reported that, after a right hip bipolar arthroplasty had been performed on (b)(6) 2007, the patient experienced pain and erosive changes of the acetabulum.This adverse event was treated by a revision surgery on (b)(6) 2018.Two components were exchanged: cocr 12/14 fem head 28 +0 ((b)(4)) and tandem bipolar cocr 46od 28id ((b)(4)), while the syn por plus ha so stem sz 11 was retained, resulting in a conversion to a total hip arthroplasty.Current health status of patient is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that, after a right hip bipolar arthroplasty had been performed on (b)(6) 2007, the patient experienced pain and erosive changes of the acetabulum.This adverse event was treated by a revision surgery on (b)(6) 2018.Two components were exchanged: cocr 12/14 fem head 28 +0 (b)(4) and tandem bipolar cocr 46od 28id (b)(4), while the syn por plus ha so stem sz 11 was retained, resulting in a conversion to a total hip arthroplasty.Current health status of patient is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms 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 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 risk management files and instructions for use found that the reported failure was documented appropriately.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or 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.

• Brand Name: COCR 12/14 FEM HEAD 28 +0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10551816
• Report Number: 1020279-2020-04657
• Device Sequence Number: 3975800
• Product Code: LPH
• UDI-Device Identifier: 03596010459664
• UDI-Public: 03596010459664
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/05/2021

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: 71309011
• Device Catalogue Number: 71302800
• Device Lot Number: 07KM01481
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 08/20/2020; 06/24/2021; 08/02/2021
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 09/18/2020; 06/30/2021; 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71302800 07KM01481 / 71322046 07BM07767; SYN POR PLUS HA SO STEM SZ 11; 71302800 07KM01481 / 71322046 07BM07767
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR