MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN LNR CON +4 10D 32IDX54OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS

Model Number	1218-32-754
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Adhesion(s) (1695); Anemia (1706); Bruise/Contusion (1754); Foreign Body Reaction (1868); Hemorrhage/Blood Loss/Bleeding (1888); Joint Dislocation (2374); No Code Available (3191)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Additional Manufacturer Narrative
(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
Fracture of the constraining ring of an implanted pinnacle® revision acetabular cup system in a condition of recurrent anterior luxations of the hip prosthesis.In 2011 primary hip-tep, after two rear luxations in 2014, revision to the above system.After a fall in (b)(6) 2019 again recurrent luxations.Now another revision in (b)(6) 2020 with fracture of the constraining ring.
Additional Manufacturer Narrative
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.Product complaint # (b)(4).Investigation summary: following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.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).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.Added: b5, h6.H6 patient code: no code available (3191) used to capture the joint instability.
Event or Problem Description
Additional information received for medical records that on (b)(6) 2019, patient experienced a fall, right hip dislocation, and bruises.Treated with closed reduction.On (b)(6) 2019, patient experienced a right hip dislocation while drying her foot.Treated with closed reduction under anesthesia.Radiographic studies revealed a fractured constraining ring.The patient continued to experience joint instability and revision was recommended.On (b)(6) 2019, patient received a liner and head revision to treat pain, joint instability, recurrent dislocations, and a fractured constraining ring.Upon entering the joint, the surgeon encountered and excised capsular metal staining.Pathology reports confirmed polyethylene particles and metallosis consistent with foreign body reaction.Periarticular scar tissue was removed.The patient was revised with competitor products.Surgical complications included postoperative bleeding anemia that did not require a transfusion.

• Brand Name: PINN LNR CON +4 10D 32IDX54OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9739603
• Report Number: 1818910-2020-05667
• Device Sequence Number: 13541916
• Product Code: KWZ
• UDI-Device Identifier: 10603295012009
• UDI-Public: 10603295012009
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K043058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/04/2020

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 Expiration Date: 05/31/2016
• Device Model Number: 1218-32-754
• Device Catalogue Number: 121832754
• Device Lot Number: 102265
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 03/11/2020; 03/11/2020; 04/03/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/17/2020; 03/23/2020; 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DLT TS CER HD 12/14 32MM +9(136532730/7889789); PINN LNR CON +4 10D 32IDX54OD(121832754/102265)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 72