MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 300 ACET CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-03-056
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
Pinnacle pfs and medical records received.Pfs alleges pain, sleeping disturbance, discomfort right leg, hip, walking difficulty and instability.Miss out work due to hip pain, surgery and recovery.Plaintiff is seeking compensation for all the injuries and financial losses.After review of the medical records the lab result mri hip reported there was a streak artifact despite metal artifact reduction.There is a mild atrophy of the right iliopsoas and hamstring tendinopathy.Mild degenerative arthrosis of the symphysis pubis and pubalgia.Cobalt and chromium result were below 7 ppb.Doi: (b)(6) 2010; dor: (b)(6) 2019; right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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.

• Brand Name: PINNACLE 300 ACET CUP 56MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• 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: 12309023
• Report Number: 1818910-2021-17618
• Device Sequence Number: 4847914
• Product Code: LPH
• UDI-Device Identifier: 10603295008675
• UDI-Public: 10603295008675
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/20/2021

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 Model Number: 1217-03-056
• Device Catalogue Number: 121703056
• Device Lot Number: E3SDM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 08/31/2021; 05/24/2022; 06/13/2022
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/01/2021; 06/13/2022; 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2010
• 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: 12/14 ARTICUL 40MM M SPEC+1.5.; APEX HOLE ELIM POSITIVE STOP.; CORAIL2 NON COL HO SIZE 12.; PINNACLE 300 ACET CUP 56MM.; PINNACLE MTL INS NEUT40IDX56OD.; UNK HIP ACETABULAR CUP PINNACLE.; UNKNOWN HIP ACETABULAR LINER.; UNKNOWN HIP FEMORAL HEAD.; UNKNOWN HIP FEMORAL STEM.; UNK HIP ACETABULAR CUP PINNACLE; UNKNOWN HIP ACETABULAR LINER; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 111 KG