MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 64MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-32-064
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Extraskeletal ossification (1428); Cyst(s) (1800); Fatigue (1849); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Litigation and medical records received.Litigation alleges that the patient continues to experience pain, sufferings and difficulty walking and elevated metal ions.Medical records reported that the reason for the persistent pain is weakness of hip abductors which was noted on physical examination.Patient also had hardened approach at the hip replacement which has led to detachment of the anterior 1/3 of the gluteus medius and minimus as noted on the mri scan that he had.Doi: (b)(6) 2011, dor: none reported, left hip.Linked to (b)(4) which captures 1st revision of left hip.
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.(b)(4).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: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot: a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number 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 device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot; a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.
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 12/18/2007 medical records report the patient had a left hip resurfacing with depuy asr on (b)(6) 2007.(b)(6) 2011 the patient was noted to have a resurfaced hip revised to a total left hip due to failure on the femoral side, fracture of the femoral neck.¿ sticker sheets note the patient had a pinnacle cup, marathon poly liner, metal femoral head, summit stem, 2 pinnacle screws and an apex hole eliminator implanted.Legal document notes that the patient was revised due to pain, and failure of fracture of the base of neck, metallosis, metal debris and a large cyst, reaction to metal ion levels, adverse local tissue reaction (b)(4).(b)(6) 2014 medical records report the patient was feeling weakness and tiredness, discomfort, and pain that radiates down to the left knee.(b)(4).On (b)(6) 2014 medical records note the patient had an aspiration of left hip.On (b)(6) 2014 and cultures came back negative for infection.It was recommend that the patient receive an injection of medication for pain.(b)(4).On (b)(6) 2014 medical records report the patient reports inability to sustain prolonged walking and standing and impaired concentration due to his pain.Patient reports his chromium shows 130mg and cobalt 17mg.Patient reports he developed a cyst due to metal in his body.(b)(4).On (b)(6) 2014 medical record (pages 1144-) the patient reports having pain over the greater trochanter, difficulty with stairs.Lab values were noted to be: chromium levels 4.7 ppb and cobalt levels 0.4ppb.Radiographs were reported to show a well fixed hip replacement with booker stage ii heterotopic ossification and small but prominent piece of bone over the greater trochanter.An ultrasound was reported to show a cystic mass over the greater trochanter.The impression of the surgeon was trochanteric pain secondary to trochanter bursitis and a prominent bone spur over the greater trochanter.The recommendation no revision for the cystic mass, there was no pseudotumor, and metal ion levels were below 7ppb.(b)(4).(b)(6) 2014 lab values are noted to be chromium 92.30 nmol/l, cobalt 13.41 nmol/l, (it should be noted that lab values had been decreasing and not at reportable range.) on (b)(6) 2015, the patient had an excision of bony exostosis, left hip, and a bursectomy to address bony exostosis and pain.During the surgery the surgeon observed a large hemosiderin-appearing deposit in the bursa, which was drained.There was bony exostosis from the greater trochanter that was removed.(page 1221 surgery) legal record noted: patient continued to have pain, limited mobility.(b)(4).(b)(6) 2015 us report notes expected appearance of left hip incision.(b)(6) 2017 mri was noted to show heterotopic bone formation superior to the greater trochanter and also an exostosis at the level of the grater trochanter.The surgeon¿s impression is the patient has a left total hip arthroplasty with no evidence for hardware failure or of osteolysis.There is a small joint effusion and dehiscence of the capsule with fluid over a portion of the greater trochanter and separation of corresponding portions of the gluteus minimus and gluteus medius tendons.The patient continued to have pain and abductor weakness.The patient received a steroid injection.(this was captured under (b)(4).
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.H11 additional narrative: added: b5, b7 and h6 (clinical codes).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 (b)(6) 2007 medical records report the patient had a left hip resurfacing with depuy asr.On (b)(6) 2011, the patient was noted to have a resurfaced hip revised to a total left hip due to failure on the femoral side, fracture of the femoral neck.Sticker sheets note the patient had a pinnacle cup, marathon poly liner, metal femoral head, summit stem, 2 pinnacle screws and an apex hole eliminator implanted.Legal document notes that the patient was revised due to pain, and failure of fracture of the base of neck, metallosis, metal debris and a large cyst, reaction to metal ion levels, adverse local tissue reaction ((b)(4)).On (b)(6) 2015, the patient had an excision of bony exostosis, left hip, and a bursectomy to address bony exostosis and pain.Patient continued to have pain, limited mobility.(b)(6) 2017 mri was noted to show heterotopic bone formation superior to the greater trochanter and also an exostosis at the level of the grater trochanter.There is a small joint effusion and dehiscence of the capsule with fluid over a portion of the greater trochanter and separation of corresponding portions of the gluteus minimus and gluteus medius tendons.(b)(6) 2018 medical; record notes patient has pain, decreased range of motion.Radiographs show heterotopic bone surrounding the greater trochanter the patient continued to have pain and abductor weakness.The patient received a steroid injection.(b)(6) 2022 patient had been having pain in right hip lately.(b)(6) 2022 patient has been having left hip pain, the assessment noted that the pain is likely generated from left trochanteric bursa.

• Brand Name: PINN SECTOR W/GRIPTION 64MM
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13344696
• Report Number: 1818910-2022-01617
• Device Sequence Number: 2959247
• Product Code: KWA
• UDI-Device Identifier: 10603295010364
• UDI-Public: 10603295010364
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/25/2022
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 1217-32-064
• Device Catalogue Number: 121732064
• Device Lot Number: EE4DR1000
• 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: 01/13/2022
• Supplement Date Received by Manufacturer: 01/28/2022; 04/03/2023; 05/02/2023; 06/21/2024
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 02/01/2022; 04/28/2023; 05/02/2023; 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2010
• 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: (64 MM SECTOR DEPUY CUP WITH GRIPTION); 36 +1.5 METAL HEAD; 6 SUMMIT STEM; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN MAR +4 NEUT 36IDX64OD; PINN SECTOR W/GRIPTION 64MM; SUMMIT POR TAPER SZ6 STD OFF; UNK HIP ACETABULAR LINER POLY; UNK HIP BONE SCREW; UNK HIP BONE SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male