MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 26 + 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71303204
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Postal code (b)(6).
Event or Problem Description
It was reported that, after thr surgery had been performed on 1999, the patient experienced an exchange of the liner in 2013 due to polyethylene wear.The original head was a cobalt chrome taper 28mm +4.The original cup was a reflection 50mm e liner.This adverse event was solved by a revision surgery in which the 32mm liner size e was inserted with a 32mm od cobalt chrome head +4mms.In a revision surgery performed on 2013.
Additional Manufacturer Narrative
Medical device problem code.
Event or Problem Description
It was reported that, after thr surgery had been performed on 1999, the patient experienced an exchange of the liner in 2013 due to polyethylene wear.The original head was a cobalt chrome taper 26mm +4.The original cup was a reflection 50mm e liner.This adverse event was solved by a revision surgery in which the 32mm liner size e was inserted with a 32mm od cobalt chrome head +4mms.In a revision surgery performed on 2013.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the patient required a liner and head revision approximately 14 years post implantation due to polyethylene wear.It was communicated that the requested medical documentation was not available for inclusion in the medical investigation.Therefore, the root cause of the reported liner and head revision could not be fully assessed nor concluded.The patient impact beyond the reported liner/¿polyethylene wear¿ and revision could not be determined.No further medical assessment is warranted 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 did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.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.Potential causes could include but are not limited to friction, joint tightness or lifetime of device.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: COCR 12/14 FEM HEAD 26 + 4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS 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: 12707944
• Report Number: 1020279-2021-07699
• Device Sequence Number: 4498781
• Product Code: LPH
• UDI-Device Identifier: 03596010194190
• UDI-Public: 03596010194190
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2009
• Device Model Number: 71303204
• Device Catalogue Number: 71302604
• Device Lot Number: 70905434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 10/07/2021; 02/03/2022
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 10/27/2021; 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 71306111/SYN POR HO FEM COM SZ 11; 740060/REF V POR ACET SHELL 60OD
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown