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

Model Number 1217-01-056

Device Problems Loss of Osseointegration (2408); Migration (4003)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Loss of Range of Motion (2032); Synovitis (2094); Weakness (2145); Osteolysis (2377); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 08/01/2017

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

The patient was revised to address osteolysis in the acetabulum, metallosis with dark soft tissue and loosening of cup at the bone to implant interface.Update 8-1-2017: medical records have been reviewed.Operative note 1-4-2005 indicates the patient received a minimally invasive two-incision right total hip replacement with s-rom component due to degenerative joint disease of the right hip.The procedure was completed with no indication of complication by the surgeon.Please take note, the medical records were difficult to read in their entirety due to what appears to be another document copied on top of the operative note.Reportability remains unchanged.Updated 8-15-2017.

Manufacturer Narrative

No device associated with this report was received for examination.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: 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.

Event Description

Patient had pain, injury, elevated metal ion but laboratory result was below 7 (no unit).Patient experienced limping and has significant impairment of activities of daily living, decreased right hip rom, weakness and difficulty with ambulation.Liner and cup were removed.X-rays revealed migration of socket.Revision notes stated that a blunt dissection was then carried out down to the bulging hip capsule.The capsule was pierced with a spinal needle and about 12 cc of "dirty dishwasher colored" synovial fluid.The synovial surface was colored brown/gray due to chronic metallosis and synovitis.A pseudotumor was traced back posteriorly into the greater trochanteric area and was removed.There was minimal trunnionosis or corrosion at the femoral head.Added patient's dob, lawyer, law firm, laboratory data and medical history.Updated product details.Corrected patient's age and ticked litigation field.Doi: (b)(6) 2005 - dor: (b)(6) 2017 (right hip).

Manufacturer Narrative

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.H10 additional narrative: e3 initial reporter occupation: lawyer.H6 patient code: no code available (3191) used to capture the device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINNACLE 100 ACET CUP 56MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6831307
• MDR Text Key: 83998103
• Report Number: 1818910-2017-23741
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008576
• UDI-Public: 10603295008576
• Combination Product (y/n): N
• PMA/PMN Number: K001534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/01/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-01-056
• Device Catalogue Number: 121701056
• Device Lot Number: YA2EL1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 12/11/2017; 06/24/2020; 07/15/2020
• Supplement Dates FDA Received: 01/03/2018; 07/07/2020; 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; PINNACLE MTL INS NEUT36IDX56OD; S-ROM M HEAD 36MM +9; S-ROM*SLEEVE PRX ZTT, 20F-LRG; SROM*STM ST,36+8L NK,20X15X165
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR