MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR HO FEM COM SZ 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71306111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Metal Related Pathology (4530)
Date of Event	01/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Bilateral patient.Plaintiff underwent medically-indicated two-stage revision of the bhr-tha left hip implants on (b)(6) 2018.(1st stage) and (b)(6) 2019 (2nd stage).On the first stage only, the stem was removed and replace with a zimmer one.At the second stage the zimmer stem was removed again along with the bhr-tha shell, head and sleeve.The patient revision surgery was performed due to severe pain, limited mobility, metallosis, pseudotumor formation, and elevated cobalt and chromium ion levels.No s&n parts remained implanted.
Additional Manufacturer Narrative
It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup, hemi head, modular sleeve and synergy stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the stem.Similar complaints have been identified for the stem, this will continue to be monitored.Similar complaints have been identified for the cup and head.However, as the devices are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.It was also confirmed that all devices were sterilized.Review of the product instructions for use found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.The root cause of the first three revisions from the multiple dislocations cannot be concluded.It is unknown what impact the reported infection, the scar tissue and the it band, (on the left atrophied, and a hole in it on the right), had on the dislocations.For the bilateral two stage revisions; the clinical information provided, of the reported elevated metal ion levels, the pseudotumor, and the necrotic tissue may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure versus the reported infection.The cultures that tested positive for bacillus species on the left and mrse on the right were likely an hematogenous infection.The impact to the patient was long term pain with multiple surgeries and recoveries to go through.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, our investigation remains inconclusive and a definitive root cause cannot be determined.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
Event or Problem Description
Bilateral patient.Plaintiff underwent medically-indicated two-stage revision of the bhr-tha left hip implants on (b)(6) 2018.(1st stage) and (b)(6) 2019 (2nd stage).In the first stage, the stem was removed and replace with a zimmer one.A functional antibiotic spacer was also placed.In the second stage, the zimmer stem was removed again along with the bhr-tha shell, head and sleeve.The patient¿s two (2) stage revision surgery was performed due to suspected bacillus hip infection, elevated metal ion levels and metallosis with adverse local tissue reaction, severe pain, limited mobility, and pseudotumor formation.No s&n parts remained implanted.

• Brand Name: SYN POR HO FEM COM SZ 11
• 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: 10908533
• Report Number: 1020279-2020-06724
• Device Sequence Number: 3217467
• Product Code: LPH
• UDI-Device Identifier: 03596010291950
• UDI-Public: 03596010291950
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2022

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: 08/29/2015
• Device Model Number: 71306111
• Device Catalogue Number: 71306111
• Device Lot Number: 05HM03377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 05/26/2021; 06/02/2022
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 05/26/2021; 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2005
• 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
• Patient Sex: Female