MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POR PL HA SZ 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71357101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Metal Related Pathology (4530)
Date of Event	05/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a bhr tha was performed on (b)(6) 2008, the patient experienced infection and metallosis.A revision surgery was performed on (b)(6) 2021 to treat these adverse events.All the components were explanted.It is unknown if the patient received any medication to treat the infection.The patient outcome is unknown.
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, 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 review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.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 contamination, patient reaction, post-operative healing issue, damaged product, implant corrosion 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.
Additional Manufacturer Narrative
H3, h6.A bhr cup (74120146, 53771), bhr modular head (74222138, 07jw13641), bhr modular sleeve (74222200 08fw17503) and anthology stem (part and lot obscured) were received for investigation following hip revision surgery for infection and metallosis.The devices were used in treatment.A review of the historical complaints data for the bhr cup, bhr head, anthology stem and modular sleeve was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures.No other complaints were identified to involve any of the device batches.No other similar complaints were identified for the part number and the reported/related failure mode for the cup, sleeve and stem.A similar complaint was found for the head.However, as the device is no longer sold, no action is to be taken.The production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.It was also confirmed that all devices were correctly sterilized.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A review of historic quality escalation actions related to the products and similar complaint events was performed.Prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible; no further escalation actions required.Visual inspection was carried out on the returned devices.A wear patch and patches of discoloration were observed on the modular head.Scratches were observed on the bearing surface of the bhr cup.Surface texture change and discoloration were observed on the internal sleeve taper.Minimal discoloration and surface texture change were observed on the external taper of the sleeve.Minimal discoloration and surface texture change were observed on the modular head taper.Discoloration was observed on the taper of the stem and damage was observed on the neck of the stem.Wear analysis was performed to review linear wear on the bearing surface of the modular head and bhr cup.The wear images identified a wear patch on the bearing surface for the bhr head, and a wear patch at the edge of the cup.Maximum linear wear for the bhr head was 125.0 m.On the bhr cup maximum linear wear was 138.1 m for a combined head & cup maximum linear wear of 263.1 m.Measurement of the vertical straightness profile of the internal sleeve taper showed material loss to a maximum depth of 63.84 m.Depth of material loss on the stem taper could not be measured with the measuring technique used due to a lack of non-contact (reference) region.Based on historic wear data, after 12.7 years in vivo, the measured combined linear wear is higher than the expected wear for a non-edge loaded smith and nephew large diameter metal-on-metal device.The position of wear on the acetabular cup shows that edge loading has occurred.Material loss was measured on the internal taper of the sleeve.The available medical documentation was reviewed.With the information provided the clinical root cause of the reported infection cannot be confirmed.Although additional clinical documentation was not provided, the product evaluation findings of surface texture change and discoloration on the internal sleeve taper and stem are consistent with findings associated with trunnionosis.It is unknown if the findings of edge loading led to trunnionosis, the reported metallosis and subsequent revision.The patient impact beyond the reported events cannot be determined.Based on the information provided and the returned device we can confirm the complaint.However, without additional information such as medical records or progressive x-rays, we cannot determine whether the devices were always misaligned, leading to the wear observed.Other specific factors that are known to contribute to the alleged fault are incorrect implantation angle or trauma to the joint replacement.No preventative or corrective action has been initiated as a result of this investigation.The devices will be retained.

• Brand Name: ANTHOLOGY HO POR PL HA SZ 1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 12011075
• Report Number: 1020279-2021-05188
• Device Sequence Number: 11844378
• Product Code: JDI
• UDI-Device Identifier: 03596010559562
• UDI-Public: 03596010559562
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2022

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 Expiration Date: 01/08/2016
• Device Model Number: 71357101
• Device Catalogue Number: 71357101
• Device Lot Number: 06AM06546A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/29/2021
• Supplement Date Received by Manufacturer: 08/09/2021; 12/15/2022
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 08/09/2021; 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2006
• 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: 74222200, LOT: 08CW16013.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown