MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 8 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number	1012-14-080
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the patient was experiencing pain for the last 2 years from a total hip.He had a size 8 trilock high offset and 56 pinnacle cup with metal on metal insert and 40 -2 12/14 taper head.The cup had 2 screws in it one looking like a 45mm and the other 20mm.Upon opening the hip a massive pseudo tumor was found encapsulating the femur.After dislocating and remove the femoral head more pseudo tumor was removed all around the acetabulum.Surrounding the trilock stem was massive bone loss on the lateral shoulder of femur into the greater trochanter along with the anterior and posterior femur.The femur was ingrown medially however with such bone loss was slap hammered out easily.We proceeded to the acetabulum where we removed metal insert and screws to test cup stability and in-growth.The component definitely had lysis around the socket however seemed stable enough to proceed.The femur was prepared and we implanted 3 screws into the existing socket with a new liner and ceramic head.It was indicated that the stem was loose at bone to implant interface.Doi: unknown; dor: (b)(6) 2018; right hip.
Additional Manufacturer Narrative
No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.No code available (3191) is used to capture blood heavy metal increased and device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
After review of the medical records, the patient was revised to address painful right total hip arthroplasty, metallosis, pseudotumor and severe bone loss with osteolysis.He has elevated metal ion levels.Revision notes reported, that a large swollen appearance with dislocation consistent with metallosis was identified in the posterior capsule, there was no fluid but rather a congealed mass of pseudotumor.There was more evidence of metallosis behind the liner.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.E3 initial reporter occupation: lawyer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: b1 (is product problem).
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 clinical code: appropriate term/ code not available (e2402) is used to capture blood heavy metal increased.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: TRI-LOCK BPS SZ 8 HI OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 6107428552
• MDR Report Key: 7788743
• Report Number: 1818910-2018-66869
• Device Sequence Number: 11346945
• Product Code: KWA
• UDI-Device Identifier: 10603295001102
• UDI-Public: 10603295001102
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/23/2018

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 Model Number: 1012-14-080
• Device Catalogue Number: 101214080
• Device Lot Number: CW8DC1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 09/13/2018; 08/07/2020; 10/12/2020; 05/11/2021; 04/21/2022
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 09/14/2018; 08/27/2020; 10/15/2020; 05/12/2021; 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2008
• 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: 12/14 ARTICUL 40MM M SPEC-2; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX45MM; PINNACLE MTL INS NEUT40IDX56OD; PINNACLE SECTOR II CUP 56MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 89 KG