MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71335552
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
''(b)(6) legal'': bilateral patient.It was reported that, after a primary r3-tha construct had been implanted on the plaintiff¿s right hip on (b)(6) 2010, the plaintiff experienced metallosis, pseudotumor formation, an inflammatory process consistent with alval lesion and loosening of the acetabular cup implant.A revision surgery was performed on (b)(6) 2019 to treat this adverse event; the bhr modular head 40mm, r3 acetabular liner co-cr and r3 three hole hemispherical stiktite coated shell 52mm were explanted.The plaintiff was taken to recovery room in good condition.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the reported ¿alval and intraoperative finding of a polylobed brownish mass with a grayish liquid, and unsealing of the cup, which was can be seen as a result of metallosis, but the loosening and/or ¿completely reversed¿ cup could also accelerate wear and lead to metal debris and result in metallosis.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported alval, and pseudotumor cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.It is noted the patient had a second revision 15 months later.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 additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason 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 abnormal motion over time, bone degeneration, lifetime of device or patient condition.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.Additional information: d3.

• Brand Name: R3 3 HOLE ACET SHELL 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12519321
• Report Number: 1020279-2021-07092
• Device Sequence Number: 16422129
• Product Code: MBL
• UDI-Device Identifier: 03596010598240
• UDI-Public: 03596010598240
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 04/10/2020
• Device Model Number: 71335552
• Device Catalogue Number: 71335552
• Device Lot Number: 10DM06069
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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; Other; Required Intervention
• Patient Age: 46 YR