MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 32 + 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71303200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	10/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, after a tha had been performed on (b)(6) 2018, the patient experienced a peri-prosthetic fracture and dislocation.A revision surgery was performed on (b)(6) 2018 where polarstem collar std.Ti/ha 01 and cocr 12/14 fem head 32 + 0 were explanted.Patient current health status in unknown.This information was provided by (b)(6) registry for (b)(6) and the (b)(4) feedback; therefore, further information is not available.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.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.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant, traumatic injury, patient anatomy, abnormal loading of limb, or surgical technique.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.
Event or Problem Description
It was reported that after a right thr had been performed on (b)(6) 2018 to address a previous hip surgery-non trauma related, the patient experienced a peri-prosthetic fracture and dislocation.A revision surgery was performed on (b)(6) 2018 where the femoral stem and the modular head were explanted and replaced with similar smith and nephew devices.This information was provided by the national joint registry of the united kingdom, as part of a retrospective data collection of patients who underwent a primary thr surgery with a hip prosthesis construct that included a polarstem stem with an r3 acetabular cup and that required a revision surgery due to specific reasons.As such, no further information will be available.
Additional Manufacturer Narrative
Sections b5, d10, d4 and h4 were updated.Section h10: the devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, smith and nephew has not received the explanted devices and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of complaint history revealed similar events for the listed devices over the previous 24 months, but no similar events for the batches based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management files and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant, traumatic injury, patient anatomy, abnormal loading of limb, or surgical technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices 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.Internal complaint reference number: (b)(4) sections a2 and h6 were corrected.

• Brand Name: COCR 12/14 FEM HEAD 32 + 0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; brooks rd. 1450; memphis 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: 12239296
• Report Number: 1020279-2021-06064
• Device Sequence Number: 19741640
• Product Code: LPH
• UDI-Device Identifier: 03596010194176
• UDI-Public: 03596010194176
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2023

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: 71303200
• Device Catalogue Number: 71303200
• Device Lot Number: 18FM01199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 08/25/2021; 03/10/2023
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/26/2021; 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2018
• 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: BIOLOX DELTA HEAD 32 MM 12/14 M / +4/UNKNOWN; PN: 71331950/ LN: 18FM17572; PN: 71337650/ LN: 18FM16481; R3 3 HOLE HA CTD ACET SHELL 48MM/UNKNOWN; R3 32MM ID INTL DLT CER LNR 48MM/UNKNOWN; BIOLOX DELTA HEAD 32 MM 12/14 M / +4/UNKNOWN; R3 3 HOLE HA CTD ACET SHELL 48MM/UNKNOWN; R3 32MM ID INTL DLT CER LNR 48MM/UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female