MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 300 ACET CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121703050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Foreign Body Reaction (1868); Granuloma (1876); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Muscular Rigidity (1968); Necrosis (1971); Nerve Damage (1979); Pain (1994); Paralysis (1997); Loss of Range of Motion (2032); Numbness (2415); Fibrosis (3167); Balance Problems (4401); Paresthesia (4421); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).(b)(4) - aug 24 2023.Reviewed (b)(4).Medical records (b)(4), were reviewed by clinician.On (b)(6) 2017 patient developed right femoral and popliteal dvt, which was treated.On (b)(6) 2017, the patient had an aspiration of right hip, which was reported to show a white blood cell count of 738 and negative gram stain and culture.A biopsy of the right hip mass demonstrated fat and fibrosis, fibrous necrosis without infection or malignancy.On (b)(6) 2017, medical records indicate integrity of femoral artery and veins and relation to synovial expansion patient with adverse local tissue reaction.Mra of lower extremity right reports finding synovial expansion with thickening and debris, consistent with adverse local tissue reaction, with surrounding muscular edema.No pseudoaneurysm, the femoral vein appears somewhat attenuated, likely related to an element of compression secondary to the aforementioned tissue reaction.On (b)(6) 2017, the patient had a right hip exploration of sciatic nerve with neurolysis, exploration of femoral nerve and femoral nerve neurolysis, resection of pseudotumor of the right hip, to address pseudotumor, status post total hip replacement, metallosis, sciatic nerve compression, femoral nerve compression.Revision total hip replacement both components right.During the procedure, the surgeon observed a fibrous tumor, metallosis, pseudotumor.The specimen also was noted to contain tissue samples that were completely necrotic with a few areas that show marked chronic inflammation with ill-defined granulomas.The history of the patient¿s present illness included that the patient had developed paralysis of the right leg from the distal thigh down.It first presented as foot drop then progressed about the knee approximately 7 months ago.Competitor components were implanted during this procedure.Post surgery, the patient became anemic and was transfused 1 unit of prbc on pod#2 (part/lot page 530 of 967 competitor products) (surgery page 505 of 967).It should be noted that at this time, depuy cup, liner, femoral head were revised and replaced with competitor components.Lab specimens note that right hip hardware noted as depuy pinnacle ultament implant composed of 50 mm spiked acetabular cup with metallic liner and a 36 +1.5 mm d4-expiration date of the device was not provided.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Pinnacle litigation record received.Litigation record alleges pain and swelling, numbness, tingling along the lateral and medial thigh, foot drop, pseudotumor and high levels of chromium and cobalt in plaintiff's blood.Doi: (b)(6) 2009 ; dor: (b)(6) 2017 (right hip).
Additional Manufacturer Narrative
Product complaint (b)(4).A-9820056 - (b)(6)2023.Reviewed -9793540, medical records ad (b)(6)2023, were reviewed by clinician.Below clinician findings for coding: on (b)(6)2017 patient developed right femoral and popliteal dvt, which was treated.On (b)(6) 2017, the patient had an aspiration of right hip, which was reported to show a white blood cell count of 738 and negative gram stain and culture.A biopsy of the right hip mass demonstrated fat and fibrosis, fibrous necrosis without infection or malignancy.On (b)(6)2017, medical records note clinical concerns is integrity of femoral artery and veins and relation to synovial expansion patient with adverse local tissue reaction.Mra of lower extremity right reports finding synovial expansion with thickening and debris, consistent with adverse local tissue reaction, with surrounding muscular edema.No pseudoaneurysm, the femoral vein appears somewhat attenuated, likely related to an element of compression secondary to the aforementioned tissue reaction.Labs note cobalt 14.3 and chromium 2.9.(b)(6)2017 lab results: chromium 2.2 ug/l, (b)(6)2017 cobalt 5.3 ug/l.On (b)(6) 2017, the patient had a right hip exploration of sciatic nerve with neurolysis, exploration of femoral nerve and femoral nerve neurolysis, resection of pseudotumor of the right hip, to address pseudotumor, status post total hip replacement, metallosis, sciatic nerve compression, femoral nerve compression.Revision total hip replacement both components right.During the procedure, the surgeon observed a fibrous tumor, metallosis, pseudotumor.The specimen also was noted to contain tissue samples that were completely necrotic with a few areas that show marked chronic inflammation with ill-defined granulomas.The history of the patient¿s present illness included that the patient had developed paralysis of the right leg from the distal thigh down.It first presented as foot drop then progressed about the knee approximately 7 months ago.Competitor components were implanted during this procedure.Post surgery, the patient became anemic and was transfused 1 unit of prbc on pod#2 (part/lot page 530 of 967 competitor products) (surgery page 505 of 967).It should be noted that at this time, depuy cup, liner, femoral head were revised and replaced with competitor components.Lab specimens note that right hip hardware noted as depuy pinnacle ultament implant composed of 50 mm spiked acetabular cup with metallic liner and a 36 +1.5 mm metallic femoral head serial # (b)(6) were part of the specimens removed.(b)(4).
Event or Problem Description
Updated event description: the patient presents abdominal pain, diarrhea, and pain in her legs.She has a history of both venous and arterial clots in her right leg and states her left leg felt cold and was painful to move when she got up to use the bathroom.She does have partial paralysis of the right leg due to a failed hip replacement in ny 5-6 years ago.Denies vomiting, fever, and chills.She is on plavix and xarelto.Denies back pain.
Additional Manufacturer Narrative
Product complaint (b)(4) investigation summary pinnacle litigation record received.Litigation record alleges pain and swelling, numbness, tingling along the lateral and medial thigh, foot drop, pseudotumor and high levels of chromium and cobalt in plaintiff's blood.Doi:on (b)(6) 2009 ; dor: on (b)(6) 2017 (right hip) an x-ray was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment "received 08-sep-2023".The x-ray evidence review revealed that the pinnacle 300 acet cup 50mm presented no evidence of a device nonconformance or relation of the product with the reported adverse event.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was unconfirmed as the observed condition of the pinnacle 300 acet cup 50mm would not contribute to the reported allegation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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.

• Brand Name: PINNACLE 300 ACET CUP 50MM
• 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, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17788597
• Report Number: 1818910-2023-19240
• Device Sequence Number: 17705566
• Product Code: LPH
• UDI-Device Identifier: 10603295008644
• UDI-Public: 10603295008644
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2023

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 Catalogue Number: 121703050
• Device Lot Number: D2TE51000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 09/28/2023; 02/20/2024
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 09/28/2023; 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2009
• 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: 6IN AML SM STATURE 12.0MM; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINNACLE MTL INS NEUT36IDX50OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White