MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF CNSTR LNR ADPTR 50-52OD E; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number 71323144

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a reflection constrained liner case the implant was laid out on the trolley in front of the surgeon to implant and the surgeon realized that the ref cnstr lnr adptr 50-52od e was not with the implant.As he had used it before he recalled the adapter had previously come in a separate box not in the box with the liner.As the implant was not useable without the ring the surgeon converted to a dual mobility cup and completed the surgery (with a competitor device).There was a delay of less than 30 min.No other complications were reported.

Manufacturer Narrative

H3, h6; the associated device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical medical investigation concluded that this complaint reports that during a reflection constrained liner case, the surgeon realized that the adapter ring was not provided with the implant, as he had previously experienced.Therefore, since the implant was not usable without the adapter.Per email communication, it was stated that this complaint is about internal process, and not the implant itself.There was no patient injury, and the procedure was completed with the surgeon converting to a competitor dual mobility cup, with a minimal delay of less than 30 minutes.No further clinical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable cause for this event could include user error or procedural variance.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.Additional information: d3.

Manufacturer Narrative

H3, h6: the associated device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical medical investigation concluded that this complaint reports that during a reflection constrained liner case, the surgeon realized that the adapter ring was not provided with the implant, as he had previously experienced.Therefore, since the implant was not usable without the adapter.Per email communication, it was stated that this complaint is about internal process, and not the implant itself.There was no patient injury, and the procedure was completed with the surgeon converting to a competitor dual mobility cup, with a minimal delay of less than 30 minutes.No further clinical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed device for the same failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable cause for this event could include user error or procedural variance.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.

• Brand Name: REF CNSTR LNR ADPTR 50-52OD E
• Type of Device: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11126303
• MDR Text Key: 225487756
• Report Number: 1020279-2021-00159
• Device Sequence Number: 1
• Product Code: KWZ
• UDI-Device Identifier: 03596010482648
• UDI-Public: 03596010482648
• Combination Product (y/n): N
• PMA/PMN Number: K033442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71323144
• Device Catalogue Number: 71323144
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1