MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71338669
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).Study: or3o.2019.08, subject id: (b)(6), ae#: 1.
Event or Problem Description
It was reported that, after a thr on an unknown date, patient experienced increased hip pain and swelling.X-rays show fracture and tests performed reveal potential infection,.A revision was performed on (b)(6) 2022, treatment not decided yet.Outcome: resolving.The current health status of patient is unknown.
Event or Problem Description
It was reported that, after a thr on an unknow date, patient experienced increased hip pain and swelling.X-rays show fracture and tests performed reveal potential infection,.A revision was performed on (b)(6) 2022, treatment not decided yet.Outcome: resolving.The current health status of patient is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).Study: or3o.2019.08, subject id: 31-005, ae#: 1.
Additional 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, this case reports, after a thr (date unspecified), the patient experienced a revision due to increased hip, swelling and a fracture which was reportedly confirmed by x-ray.Per case correspondence, test performed revealed a possible infection.It has been reported that treatment is yet to be decided, however the outcome is reportedly resolving.No additional requested information was provided.Without the requested information, the root cause of the ¿patient experienced increased hip, swelling, ¿potential infection¿ and a subsequent revision cannot be definitively concluded.The patient impact beyond the reported symptoms and events cannot be determined and the patient¿s outcome is reportedly ¿resolving¿.Therefore, no further medical assessment can be rendered.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for hip systems revealed that infection, both early, post-operative superficial, early, post-operative deep wound infection, late periprosthetic infection and implant fracture have been identified as a potential complications and adverse events in primary and revision surgery respectively.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.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, contamination, patient reaction, and post-operative healing issue 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.

• Brand Name: R3 MULTI HOLE ACETABULAR SHELL 60MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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: 14192054
• Report Number: 1020279-2022-01943
• Device Sequence Number: 11845412
• Product Code: MBL
• UDI-Device Identifier: 00885556020364
• UDI-Public: 00885556020364
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K092386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71338669
• Device Catalogue Number: 71338669
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 03/29/2022; 05/19/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 04/26/2022; 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNKN FEMORAL HEAD IMPL; UNKN FEMORAL HEAD IMPL; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN R3 CERAMIC LINER; UNKN R3 CERAMIC LINER
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown