MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN SYNERGY HIP STEM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that, after a thr surgery had been performed on an unspecified date, the patient presented pain on the left hip, which caused a revision surgery on (b)(6) 2021.On opening of the capsule a large amount of metallosis was found due to the wear from the taper/stem.Cup and stem were removed and a full tha revision was performed as well as a debridement of the surrounding tissue.The patient's outcome is unknown.

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the reported symptoms it cannot be concluded that the events/clinical reactions (pain and large amount of metallosis) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.No further clinical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Potential causes could include but are not limited to friction, joint tightness or lifetime of device.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.

Manufacturer Narrative

H3, h6: a bhr modular head (part 74222144), sleeve (part and lot obscured), bhr cup (74122152, 08hw18303 sn (b)(6)) and synergy stem (part and lot obscured) were received for investigation following left hip revision surgery.The devices were used in treatment.A review of the historical complaints data for the acetabular cup 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 or defects in a timeframe prior 12 months as of the complaint aware date.Other complaints were identified to involve this batch.Other similar complaints were identified for the part number and the reported/related failure mode.However, as the device is no longer sold, no action is to be taken.A review of the historical complaints data for the head was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.As no part or batch numbers were identified for the, sleeve and stem a complaint history review for these devices could not be performed.The production records were reviewed for the devices involved in this incident for which device details were available.All released devices involved met manufacturing specifications upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.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 escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.Visual inspection was carried out on the returned devices.Scratches were observed on the bearing surface of the bhr cup and modular head.Damage was observed to the taper and neck of the stem.Damage was also observed to the base of the head taper.Surface texture change and discolouration were observed on the internal sleeve taper.The sleeve could not be removed from the head without using excessive force.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 on the bhr cup.The position of wear on the acetabular cup shows that the femoral head was articulating within the bearing surface of the cup.Maximum linear wear for the bhr head was 19.8¿m.On the bhr cup maximum linear wear was 23.2¿m for a combined head & cup maximum wear of 43.0¿m.Measurement of the vertical straightness profile of the internal sleeve taper showed material loss to a maximum depth of 318.0 ¿m.The depth of material loss on the stem taper could not be measured due to a lack of sufficient non-contact (reference) region.Time in vivo is needed to compare the measured combined linear wear for this device with the historical wear data for a non-edge loaded smith and nephew large diameter metal-on-metal device.The position of wear on the acetabular cup shows that the femoral head was articulating within the bearing surface of the cup.Material loss was measured on the internal taper of the sleeve.Damage could be observed on the taper of the stem, but the depth of material loss on the stem taper could not be measured due to a lack of sufficient non-contact (reference) region.A medical investigation was performed.The product evaluation was reviewed and the noted, material loss on the internal taper of the sleeve, surface texture change and discoloration on the internal sleeve taper which may be consistent with the reported ¿large amount of metallosis due to the wear from the taper/stem.¿ however, as of the date of this medical investigation, the requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the wear on the taper/stem.The patient impact beyond the reported clinical reactions and revision cannot be determined.Based on the information provided, the reported wear on the sleeve and stem can be confirmed.However a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on the replacement system, excessive patient weight and trauma to the joint replacement.Based on this investigation the need for corrective and preventative action is not indicated.The devices will be retained.

• Brand Name: UNKN SYNERGY HIP STEM
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 14232492
• MDR Text Key: 290259698
• Report Number: 1020279-2022-02023
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 04/28/2022
• Supplement Dates Manufacturer Received: 05/04/2022; 11/04/2022
• Supplement Dates FDA Received: 05/09/2022; 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male