MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ASPHERE M SPEC 12/14 36 +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-51-100
Medical Device Problem Codes	Naturally Worn (2988); Noise, Audible (3273)
Health Effect - Clinical Codes	Fatigue (1849); Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Discomfort (2330); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 revised due to metalosis.Ultamet metal liner/head.The hip joint was black and green with metal debris.Additional information event in the der reported osteolysis.Product issues was suspected and contributed to the event.Doi: unknown: dor: (b)(6) 2021: left hip.
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 complaint database search and/or device manufacturing (dhr) reviews will not be performed.Per (b)(4) it has been determined that should related reports be identified a dhr review is not required.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : update 29-mar-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) will not be performed since mom systems are obsolete.H10 additional narrative: added: b2 (is required intervention), b5, d5, d6a, d10, g2 and h6 (clinical codes).H6 clinical symptoms code: appropriate term/code not available (e2402) used to blood heavy metal increased.Corrected: e1, e2 and e3.E3 initial reporter occupation: lawyer.
Event or Problem Description
Litigation alleges heavy metal poisoning of toxic heavy metals, muscle, tissue injury, scar tissue formation, metal wear and limited adl.Plaintiff also experience pain, emotional trauma and distress.Due to damages plaintiff demand compensation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- update (b)(6) 2023.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.
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.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 a review of the operative notes and sticker sheets, the patient reported having pain beginning several years earlier and it simply continued to worsen.The patient currently rates his pain as 5/10.Pain is improved with rest.The patient also noted some squeaking in the hip that is audible to him and others.
Event or Problem Description
Medical records were received and stated the following: the patient was revised due to significant elevated metal levels, as well as severe pain and discomfort, failed left total hip arthroplasty with metal on metal components with metallosis and osteolysis with pseudotumor, there was a portion of the pseudotumor that had formed in the hip that had herniated through the it band.There was osteolysis identified posterior inferior extending down into the ischium.A cured curette was utilized to thoroughly debride this area, removing all osteolytic tissues.Doi: (b)(6) 2010.Dor: (b)(6) 2021.Left hip.
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.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 : the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-ray evidence was not able to confirm the complaint since it was not possible to observe signs of wear of metal material or audible sound.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.
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.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
Medical records were received: in addition to what was previously reported after review the patient was revised to address chronic fatigue.Operative note reported excised.There was minimal fluid aspirated and was sent for synovasure.There was a thicked native posterior capsular tissue.There was no significant osteolysis about the femoral implant.Stem remained in good condition.The cup was approx.5 degrees of abduction and it was anteverted to approx.45 degrees.The entire acetabular component were removed.There was osteolysis involving the acetabulum involving the anterior wall.Surgical inflammation and pigment laden histiocytes infiltration.Pathology report of pseudo capsule with marked hyalinization, central degenerative changes and patchy mild chronic.Iron stain shows' minimal hemosiderin.Cauterized pink tan, rubbery, soft tissue with dusky green gray, necrotic tissue.No infection found.Clinical visit reported hip pain, squeaking, popping and clicking.Doi: (b)(6) 2010; dor: (b)(6) 2021; left hip.

• Brand Name: ASPHERE M SPEC 12/14 36 +1.5
• 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 ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11613799
• Report Number: 1818910-2021-06973
• Device Sequence Number: 2905110
• Product Code: KWA
• UDI-Device Identifier: 10603295033929
• UDI-Public: 10603295033929
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K082585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• 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): 03/18/2021
• 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: 06/30/2014
• Device Model Number: 1365-51-100
• Device Catalogue Number: 136551100
• Device Lot Number: 2946131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/15/2021; 03/29/2022; 03/01/2023; 03/23/2023; 05/20/2023; 06/06/2023; 08/21/2023
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 04/16/2021; 03/29/2022; 03/13/2023; 03/23/2023; 05/26/2023; 06/06/2023; 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2009
• 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: 36+1.5 M SPEC HEAD.; 54 MM PINNACLE CUP.; 54X36 MM ULTAMET LINER.; ASPHERE M SPEC 12/14 36 +1.5.; PINNACLE MTL INS NEUT36IDX54OD.; PINNACLE SECTOR II CUP 54MM.; TRI-LOCK BPS SZ 7 STD OFFSET.; UNKNOWN HIP FEMORAL STEM.; 36+1.5 M SPEC HEAD; 54 MM PINNACLE CUP; 54X36 MM ULTAMET LINER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White