MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OR3O DUAL MOBILITY TRIAL LINER 42/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Catalog Number	71353304
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during thr, the ring that retains the screw into the or3o dual mobility trial liner 42/54 broke when inside the patient.All the pieces were recovered.No surgical delay reported and the procedure was completed with the same device.
Additional Manufacturer Narrative
The device, used in treatment was returned for evaluation.Visual inspection of the returned trial liner confirms that the device is broken and damaged.The returned trial liner has little signs of wear and tear from use.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 revealed prior complaints for the listed batch and failure mode.A medical investigation was conducted and confirms per complaint details, the device broke during use; however, all pieces were recovered, and the procedure was completed with the same device¿.Reportedly, there was no patient injury, no retained foreign bodies, no delay or additional complications.The product evaluation confirmed the reported failure but did not provide a possible root cause of the event.Based on the information provided, the clinical root cause could not be definitively concluded.Patient impact beyond retrieval of the broken pieces would not be anticipated.Since no patient injury or delay was reported, no further medical investigation 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.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.A review of risk management files found that the reported failure was documented appropriately.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: OR3O DUAL MOBILITY TRIAL LINER 42/54
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11773174
• Report Number: 1020279-2021-03719
• Device Sequence Number: 3778044
• Product Code: LPH
• UDI-Device Identifier: 00885556710470
• UDI-Public: 885556710470
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K191002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71353304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 07/22/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention