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); Noise, Audible (3273)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Joint Laxity (4526); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	11/09/2021
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 surgeon revised the 54 ultamet liner due to hip pain & metallosis.Surgeon removed the metal liner and replaced with an altrx liner.Doi: (b)(6) 2010 - dor: (b)(6) 2021 (right 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 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.Added: b5, h6 health effect - clinical code.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
Litigation records received.After a review of records, plaintiff reported that was forced to undergo surgical removal of the defective pinnacle system due to heavy metal poisoning and suffered an injury to his muscle and tissue, and suffered additional scar tissue formation.Plaintiff suffered injuries, including but not limited to significant pain, corrosion, stained tissue, metal wear, metal poisoning, instability, loss of enjoyment of life, and limitation of daily activities.
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 received.Revision notes stated that there was grayish yellow-colored fluid and noted a black color at the trunnion and had impingement of the neck to the component.
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 received on 01/24/2011, visit note reported patient had complained that his hip was popping at times with aching pain.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.The reported allegation cannot be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.H10 additional narrative: added: b7, d4 (expiration).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 LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12861375
• Report Number: 1818910-2021-26171
• Device Sequence Number: 14560425
• Product Code: KWA
• UDI-Device Identifier: 10603295033943
• UDI-Public: 10603295033943
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/09/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2015
• Device Model Number: 1365-52-100
• Device Catalogue Number: 136552100
• Device Lot Number: 3056293
• 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: 11/09/2021
• Supplement Date Received by Manufacturer: 12/17/2021; 03/29/2022; 03/01/2023; 03/28/2023; 06/27/2023; 10/18/2023
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/20/2021; 04/08/2022; 03/08/2023; 04/12/2023; 06/28/2023; 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2010
• 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: ASPHERE M SPEC 12/14 36 +5; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54MM; PRODIGY LG STAT SHT RT 12.0MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male