MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STANDARD OFFSET NEUTRAL MODULAR NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71352111
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Laceration(s) (1946); Metal Related Pathology (4530)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
Us legal, it was reported that, after a left thr on (b)(6) 2012 due to osteoarthritis, plaintiff has experienced an implant mechanical failure, significant elevated cobalt chromium levels and an mri showed an abductor muscle tendon tear.A revision surgery was performed on (b)(6) 2021 where it was found a pseudotumor engulfing the abductor muscle, after a debrided there was a large disruption of the entire muscle and it was noticed the femoral component down to the acetabular component and corrosion at the modular neck to stem interface.The r3 3 hole acet shell 56mm remained and was not explanted.Patient outcome is unknown.
Additional Manufacturer Narrative
H10: the device was not returned for evaluation but the elevated cobalt chromium levels were confirmed.The clinical/medical investigation concluded that, based on the reported symptoms it cannot be concluded that the events/clinical reactions (elevated cobalt chromium levels, muscle tendon tear, pseudotumor, and corrosion) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.No further clinical 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 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 risk management file and instructions for use documents revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that a similar event was identified and addressed through a market removal of the product.At this time, we have reasons to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include damaged product, implant corrosion, material in use, patient reaction or wear.The contribution of the device to the reported event could be corroborated since the product number and lot number are within the scope of a health hazard evaluation.Based on this investigation, the need for corrective action was indicated, the product was removed from the market.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.Internal complaint reference number: (b)(4).

• Brand Name: STANDARD OFFSET NEUTRAL MODULAR NECK
• 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: 12953064
• Report Number: 1020279-2021-08541
• Device Sequence Number: 5188181
• Product Code: LPH
• UDI-Device Identifier: 03596010619532
• UDI-Public: 3596010619532
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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 Expiration Date: 06/26/2021
• Device Catalogue Number: 71352111
• Device Lot Number: 11FTM0004D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2011
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 84 YR
• Patient Sex: Male