MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71331854
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	08/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Bilateral patient.It was reported that a second revision surgery was performed the patient left hip on (b)(6) 2018.The revision surgery was performed due to metalosis.The cup, head, liner and sleeve were removed, only the stem was left inside the patient.Depuy parts were implanted.Although the patient is a bilateral one and elevated ion levels (metalosis) was reported the right hip construct consist of ceramic parts, therefore there is no contribution of the right hip construct to the elevated ion levels that provoke the second revision surgery.The patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the intraoperative findings of pseudotumor as well as the reported cobalt toxicity and subsequent deafness, blindness, hypothyroidism, and tachycardia may be consistent with metal debris as a result of having metal components implanted after fractured ceramic implants.This was also confirmed by the surgeon noting wear in the revised components.The patient impact cannot be determined; however, a physician¿s post revision follow-up note indicated, from a hip perspective she has recovered beautifully.Having less trouble with tach.Being followed by internist and cardo at home, has bilateral hearing aids and wears glasses.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include damaged product, implant corrosion or wear.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: R3 0 HOLE ACET SHELL 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11616780
• Report Number: 1020279-2021-02692
• Device Sequence Number: 14252159
• Product Code: MBL
• UDI-Device Identifier: 03596010597601
• UDI-Public: 03596010597601
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 09/17/2020
• Device Model Number: 71331854
• Device Catalogue Number: 71331854
• Device Lot Number: 10JM12268
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention