MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POR PL HA SZ 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Model Number	71357111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Ambulation or Postural Difficulties (2544); Malunion of Bone (4529)
Date of Event	11/19/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a bhr-tha had been performed on the patient¿s right hip on (b)(6) 2009, the patient turned in his kitchen, his left foot dragged and suddenly lost his balance and fell onto his right side.The patient sustained a minimally displaced right greater trochanteric hip fracture on (b)(6) 2015.The treating surgeon recommended nonoperative treatment with toe-touch weightbearing on his right lower extremity without abduction exercise to his right hip, but the fracture became more displaced with a malunion diagnosis as revealed by radiographic assessment on (b)(6) 2016.Although an orif procedure was discussed as a potential solution, the patient declined this option and decided to continue with the conservative treatment.The fracture eventually healed as confirmed by radiographs performed on (b)(6) 2018.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the reported displaced right greater trochanteric hip fracture was related to the patient¿s fall onto his right side.The fracture healed with conservative treatment measures of toe-touch weight bearing.It cannot be concluded the fracture was related to a malperformance of the implant.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that trauma, strenuous activity can increase the risk of femoral or pelvic fractures as warnings and precautions.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 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 patient bone quality and/or traumatic injury.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 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: ANTHOLOGY HO POR PL HA SZ 11
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: 15665738
• Report Number: 1020279-2022-04555
• Device Sequence Number: 2749218
• Product Code: MRA
• UDI-Device Identifier: 03596010559661
• UDI-Public: 03596010559661
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K211176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2019
• Device Model Number: 71357111
• Device Catalogue Number: 71357111
• Device Lot Number: 09AM13681A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEMI HEAD 46MM, LOT#:08JW18836; MODULAR SLEEVE {} PLUS 0MM 12/14, LOT#:08JW19035; R3 3 HOLE ACET SHELL 58MM, LOT#:08MM13322; R3 46MM ID US COCR LNR 58MM, LOT#:08MW20868
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male