MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71335558
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a recalled r3 3 hole acet shell 58mm was implanted into a patient during a thr on (b)(6) 2021.This was noticed after surgery by the sales rep who covered the case.It is also unknown if the patient has had any problem with that implant.It is also unknown if a surgical intervention is planned to address the problem.The facility had other consignment implants of the same sized shell at this account.
Additional Manufacturer Narrative
The device was not returned for evaluation, however the reported event could be confirmed since the batch number is part of recall r-2020-04.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 for the part number over the past 36 months and for the batch number based on historical data of the device, did not reveal events where a recalled device was implanted, however it did reveal a similar event to the ones that led to the recall action.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 do have reason to suspect that the product failed to meet product specifications at the time of manufacture.Manufacturing process errors could be the probable cause for the recall action.Probable cause for the implantation of a recalled device is errors during the communication process.The contribution of the device to the reported event could be corroborated since the device was part of recall r-2020-04.This issue was previously identified and is being addressed though our internal quality hold process.Based on this investigation, the need for corrective action is indicated.A series of improvements in the inspection process were performed to correct the issue that led to the recall.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
Additional Manufacturer Narrative
H7: if remedial action initiated, check type b5: describe event or problem, d4: lot number, expiration date and h4: device manufacture date.
Event or Problem Description
It was reported that shortly after implantation the patient bent over and felt a pop.Revision surgery was subsequently performed in early 2019, during which the surgeon noticed that the liner had become disengaged from the r3 shell.Only the liner was revised.

• Brand Name: R3 3 HOLE ACET SHELL 58MM
• 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: 12038922
• Report Number: 1020279-2021-05303
• Device Sequence Number: 3662692
• Product Code: MBL
• UDI-Device Identifier: 03596010598271
• UDI-Public: 03596010598271
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71335558
• Device Catalogue Number: 71335558
• Device Lot Number: 18JM17689A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 03/03/2022; 09/22/2022
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 03/08/2022; 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2331-2020
• Patient Sequence Number: 1
• Patient Sex: Unknown