MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 53OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	71322053
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Laxity (4526)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a hemi-arthroplasty was performed on (b)(6) 2022, the patient experienced hip instability.A revision surgery was performed on (b)(6) 2022 to revise to total; however, during the surgery it was found that the syn cem fem comp sz 14 was loose and pulled out with ease.Also, it was found that there was a possible patient infection, and that no bone cement was bonded to stem.Therefore, the tandem bipolar cocr 53od 28id, the invis dist cent sz 11mm and the oxinium fem hd 12/14 28mm +0 were explanted along with the stem.The patient is currently on the first stage of a two-stages revision surgery, for which a cement spacer is being used.No further information is available.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a total hip arthrosplasty (tha) revision was performed 2 months post hemi-arthroplasty due to instability with intraop findings of a loose stem/¿no bone cement bonded to stem¿ and ¿possible patient infection¿.Reportedly, a first stage (of a two-stage) revision with a cement spacer was performed instead of the planned revision/conversion to a tka which resulted in a greater that 30 minute surgical delay.It was communicated that the requested clinical documentation will not be provided and the explants are hospital property.Without the requested documentation, further root cause analysis cannot be performed.Although a 2nd stage revision is anticipated, the patient impact beyond the reported suspect infection, loosened stem/lack of cement bond at implant/cement interface, change in surgical technique, part 1 of a 2-stage revision, and > 30 minute surgical delay cannot be determined.No further medical assessment can be rendered at this time.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 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for endoprostheses systems revealed that loosening has been identified as possible adverse effects.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the sterilization records revealed the batch was sterilized within normal parameters.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.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.

• Brand Name: TANDEM BIPOLAR COCR 53OD 28ID
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• 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: 14545521
• Report Number: 1020279-2022-02674
• Device Sequence Number: 6633693
• Product Code: KWY
• UDI-Device Identifier: 03596010492524
• UDI-Public: 03596010492524
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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
• Operator of Device: Health Professional
• Device Model Number: 71322053
• Device Catalogue Number: 71322053
• Device Lot Number: 18KM06749
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INVIS DIST CENT SZ 11MM, LOT#:21FM05514.; RALLY MV BONE CEMENT 40 GRAMS, LOT#:21MTC0183.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown