MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ASPHERE M SPEC 12/14 36 +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-52-100
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent revision of the stem and liner of the left hip.Patient had pinnacle mom liner and a corail hip stem.Patient was experiencing pain and on x-ray showed metallosis around the stem.Surgeon said that he did not see any damage to the soft tissues but there was a lot of bone loss around the stem and it was grossly loose.Femoral stem was loose at a non-cemented interface.The corail stem came out with the surgeon's fingers.There were noticeable markings on both the metal liner and trunnion.Surgeon thought the cup was in good position and well fixed so he decided to leave in place.Removed both the metal liner, stem and head and replaced them with a poly liner, reclaim stem and ceramic head.Doi: unknown, dor: (b)(6) 2022, affected side: left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary = > n update: 23-nov-2022.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 = > a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.H10 additional narrative: h6 clinical symptoms code: metal related pathology (e1618) used to capture blood heavy metal increased and metal poisoning.Corrected: e2, e3 and (h6 (device code) e3 initial reporter occupation: lawyer.
Event or Problem Description
Litigation records received.The patient was revised due to heavy metal poisoning.Records alleges metal wear, injury, scar tissue formation and limitation of daily activities.
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: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
Event or Problem Description
After review of the medical records, the patient was revised to address hip pain, severe proximal femur osteolysis due to metal reaction, and trunnionosis of the left tha.Operative note reported dark-colored fluid consistent with a metal reaction in the left hip.There was significant debris within the hip and consistent with metal reaction and osteolysis.The femoral stem was grossly loose and have black material on it.The femoral head showed black material consistent with trunnionosis.These were all adequately debrided.
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.H6: metal related pathology (e1618) is being utilized to capture blood heavy metal increased & metal poisoning.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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
Event or Problem Description
Medical records received.Medical records report failure of left total hip arthroplasty with metal on metal articulation, severe proximal femur osteolysis due to metal reaction, and trunnionosis of the left total hip arthroplasty.Changes of bilateral hip arthroplasty was also reported.There is a small area of increased t2 signal within the central marrow distal to the left femoral component.There is a small amount of the adjacent periosteal edema.Findings may resent surgical artifact versus a stress reaction.7 ml of brown serous fluid was aspirated fluoroscopically guided right hip arthrocentesis.There was dark-colored fluid that was easily seen, consistent with a metal reaction in the left hip.In looking around the proximal femur as well as around the hip, there was significant debris within the hip, consistent with a metal reaction.The trunnion did have black material present.In addition the cobalt chromium femoral head also showed black material throughout.This is consistent with trunnionosis.Therefore patient had this in addition to the metal on metal articulation that likely lead to the metal reaction in the hip which then led to the severe osteolysis.Medical records report corrosion.
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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ASPHERE M SPEC 12/14 36 +5
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15321510
• Report Number: 1818910-2022-16910
• Device Sequence Number: 5517970
• Product Code: KWA
• UDI-Device Identifier: 10603295033943
• UDI-Public: 10603295033943
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/30/2022
• 2 Devices were Involved in the Event: 1 2

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: 11/30/2015
• Device Model Number: 1365-52-100
• Device Catalogue Number: 136552100
• Device Lot Number: 3225881
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 09/12/2022; 11/23/2022; 03/01/2023; 03/09/2023; 08/21/2023
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/12/2022; 11/23/2022; 03/08/2023; 03/09/2023; 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2010
• 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: CORAIL AMT COLLAR SIZE 9; PINNACLE MTL INS NEUT36IDX50OD; PINNACLE MTL INS NEUT36IDX50OD; PINNACLE SECTOR II CUP 50MM; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL STEM CORAIL; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 91 KG