MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE SECTOR II CUP 52MM; HIP ACETABULAR CUP

Catalog Number 121722052

Device Problem Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pain (1994); Skin Irritation (2076); Tissue Damage (2104); Joint Disorder (2373); Osteolysis (2377)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clinical der states that patient's ae for abnormal radiographic evaluation - osteophyte lesion in charnley and delee zone 1.Mild calcar resorption, minimal scalloping.Event meets the definition of serious and is considered moderate.Event is probably related to the device and definitely not related to the procedure.Event is awaiting resolution.Update sep 29, 2017.Medical records reviewed.Primary operative notes indicate the patient received a left press fit total hip arthroplasty due to osteoarthritis end stage, left hip.Completed without indication of complication by the surgeon.Mri notes reveal a fluid collection noted along the posterior-lateral aspect of the proximal femur.Findings are compatible with pseudotumor formation.Findings also suggest ischial femoral impingement.Atrophy and edema involving the femoris muscle, obturator internus and gluteus minimus muscle.No evidence of fracture stress reaction.Prosthetic components appear to be in satisfactory position.Office notes (b)(6) 2017 indicate the patient is bilateral metal-on-metal hip arthroplasties.The left hip has been in for about 15 years and has more recently started to produce more symptoms.An mri performed last may revealed a bit of fluid collection, appearing to be an early adverse reaction to metal debris.Office notes indicate she is experiencing more groin pain and more buttock pain.It is harder for her to take part in activities.X-rays taken at the office visit reveal no interval change since the last year.Changes consistence with early osteolysis and adverse reaction to metal debris.Revision notes not provided within the document.Updated 10-24-2017.Update oct.04, 2017 patient was revised to address metallosis.Depuy head and liner were revised.

Manufacturer Narrative

Product complaint #
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> pc-000103251 investigation summary
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> 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
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> null device history lot
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> null device history review
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> null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Complaint description: clinical der states that patient's ae for abnormal radiographic evaluation - osteophyte lesion in charnley and delee zone 1.Mild calcar resorption, minimal scalloping.Event meets the definition of serious and is considered moderate.Event is probably related to the device and definitely not related to the procedure.Event is awaiting resolution.Update (b)(6) 2017 patient was revised to address metallosis.Depuy head and liner were revised.Update sep 29, 2017.Medical records reviewed.Primary operative notes indicate the patient received a left press fit total hip arthroplasty due to osteoarthritis end stage, left hip.Completed without indication of complication by the surgeon.Mri notes reveal a fluid collection noted along the posterior-lateral aspect of the proximal femur.Findings are compatible with pseudotumor formation.Findings also suggest ischial femoral impingement.Atrophy and edema involving the femoris muscle, obturator internus and gluteus minimus muscle.No evidence of fracture stress reaction.Prosthetic components appear to be in satisfactory position.Office notes 8-2-2017 indicate the patient is bilateral metal-on-metal hip arthroplasties.The left hip has been in for about 15 years and has more recently started to produce more symptoms.An mri performed last (b)(6) revealed a bit of fluid collection, appearing to be an early adverse reaction to metal debris.Office notes indicate she is experiencing more groin pain and more buttock pain.It is harder for her do take part in activities.X-rays taken at the office visit reveal no interval change since the last year.Changes consistence with early osteolysis and adverse reaction to metal debris.Revision notes not provided within the document.Updated (b)(6) 2017.Update oct 4, 2017.Der reviewed.Der indicates revision of depuy head and liner due to metallosis.Reportability has been updated.10-24-2017./ | investigation method: no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found one additional report against the metal liner product code/lot code combination.A dhr review performed at that time found no related deviations or anomalies.No additional related reports are found against the remaining product/lot combinations on this report.Based on the inability to find any additional related reports against the provided product code/lot code combination(s) it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.The reported event is considered one of the possible complications of joint replacement.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.- without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event./ | investigation summary: clinical der states that patient's ae for abnormal radiographic evaluation - osteophyte lesion in charnley and delee zone 1.Mild calcar resorption, minimal scalloping.Event meets the definition of serious and is considered moderate.Event is probably related to the device and definitely not related to the procedure.Event is awaiting resolution.Doi: (b)(6) 2001 ae: (b)(6) 2017 left hip.

• Brand Name: PINNACLE SECTOR II CUP 52MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; depuy orthopaedics, inc. 18189; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 6998129
• MDR Text Key: 90932433
• Report Number: 1818910-2017-27963
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009825
• UDI-Public: 10603295009825
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 121722052
• Device Lot Number: WD2G21003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 11/02/2017
• Supplement Dates Manufacturer Received: 02/05/2018
• Supplement Dates FDA Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 59