MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-01-054
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Osteolysis (2377); Joint Laxity (4526); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Clinical notification received for revision of right total hip to address dislocation.Primary operative notes (b)(6) 2010 indicate the patient received a right total hip replacement due to end stage osteoarthritis.The surgery was completed without indication of complication by the surgeon.Office notes (b)(6) 2021 indicate the patient is experiencing pain, swelling, stiffness and episodes of subluxation in her right hip.Revision operative notes (b)(6) 2021 indicate the patient received a right total hip revision due to adverse reaction to metal debris, pain, osteolysis and avascular facia soft tissue.Intra-op findings include bone loss, and fracture of the tip of the trochanter.It was noted that the metal liner was cold-welded to the acetabular shell and unable to be removed ¿ therefore, the entire cup was removed.The stem was well fixed and retained.The surgery was completed without indication of complication by the surgeon.There is no mention of a hip dislocation beyond the episodes of subluxation noted in office notes.Date of implantation: (b)(6) 2010; date of revision: (b)(6) 2021; (right hip).Treatment: revision of cup, hole eliminator, liner, and head.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.The x-rays provided as evidence were taken post revision, so from an investigation standpoint is impossible to link the allegation against the device with the evidence provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 100 ACET CUP 54MM
• 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: 12737641
• Report Number: 1818910-2021-24163
• Device Sequence Number: 4920811
• Product Code: LPH
• UDI-Device Identifier: 10603295008569
• UDI-Public: 10603295008569
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 1217-01-054
• Device Catalogue Number: 121701054
• Device Lot Number: E3XHW1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2010
• 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: APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD; S-ROM M HEAD 36MM +3; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM STM STD 36+12L 13X18; APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD; S-ROM M HEAD 36MM +3; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM STM STD 36+12L 13X18
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White