MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA SO STEM SZ 12; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number	71309012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	05/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Us legal mdl.It was reported that the patient underwent medically indicated revision of the bhr cup and the cobalt-chronium modular head of the right hip on (b)(6) 2020.The patient revision surgery was performed due to severe pain, limited mobility, metallosis, elevated cobalt and chromium levels, and adverse local tissue reaction.Intra-operative findings from the revision surgery performed indicate large fluid collection in hip joint.The stem was also revised due to inadequate stability.The patient was stable after the procedure.
Additional Manufacturer Narrative
It was reported that right 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 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 bhr cup, hemi head and stem.Similar complaints have been identified for the modular sleeve.However, as the device is 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.All the released devices involved met manufacturing specifications at the time of production.The manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Review of the product ifu 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 and no further actions are required at this time.The available medical documents were reviewed.The implantation report indicated the acetabular component was impacted into position in 15 degrees of anteversion; however, the surgeon noted during the revision ¿his cup only had about 10 degrees of anteversion on it.¿ therefore, micro-motion over time cannot be ruled out as a contributory factor to the reported pain and clinical reactions.With the information provided the clinical root cause of the reported pain, elevated metal ions, large fluid collection and ¿metallosis¿ could not be confirmed and it could not be concluded that the reported pain and clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.A potential root cause is improper loading of the cup due to the reduced anteversion.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.

• Brand Name: SYN POR PLUS HA SO STEM SZ 12
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11849376
• Report Number: 1020279-2021-04452
• Device Sequence Number: 19781336
• Product Code: MEH
• UDI-Device Identifier: 03596010459671
• UDI-Public: 03596010459671
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K002996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2021

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: 05/27/2018
• Device Model Number: 71309012
• Device Catalogue Number: 71309012
• Device Lot Number: 08DM06509A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention