MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-01-056
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Pain (1994); Osteolysis (2377); Numbness (2415); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021: patient has a consult regarding his right hip with persistent swelling that has occurred nearly a year after his revision.He has been aspirated several times with no signs of infection.Chromium and cobalt levels are normal.He has some numbness and pain radiating down the back of his leg.Mri shows a very large pseudotumor around the right hip that has recurred as well as possible loosening of the right cup.X-ray review shows osteolysis around the stem proximally on the medial side.On (b)(6) 2022: physical therapy note indicates patient had a second pseudotumor removal from his hip on (b)(6) 2021.He has weakness and difficulty walking requiring physical therapy treatments.It is unknown if any implants were revised.On (b)(6) 2022: patient cancels physical therapy visits due to excessive ¿popping sounds¿ in his hip.Doi: (b)(6) 2020; dor: unknown; right hip second complaint.
Additional Manufacturer Narrative
Product complaint # (b)(4).E3 initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 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.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.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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 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: b5, h6 (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
On (b)(6) 2022, x-ray findings right total hip prosthesis with acetabular cup and femoral stem indicated that there were no significant changes in irregularity and minimal heterotopic ossification involving the right greater trochanter.Surgical drain in place with small amount of pneumarthrosis and subcutaneous emphysema.No evidence of periprosthetic fracture.

• Brand Name: PINNACLE 100 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, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16852332
• Report Number: 1818910-2023-09307
• Device Sequence Number: 20745193
• Product Code: LPH
• UDI-Device Identifier: 10603295008576
• UDI-Public: 10603295008576
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• 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): 05/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1217-01-056
• Device Catalogue Number: 121701056
• Device Lot Number: Z48ET1000
• 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: 04/07/2023
• Supplement Date Received by Manufacturer: 06/06/2023; 07/12/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/06/2023; 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2005
• 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: ALTRX +4 10D 40IDX56O; DLT TS CER HD 12/14 40MM +8.5; PINNACLE 100 ACET CUP 56MM; SOL SYS 8/18.0 LRG ST
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male