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

Catalog Number 121722056

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870); Unspecified Infection (1930); Nausea (1970); Pain (1994); Anxiety (2328); Depression (2361); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 12/03/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Us fda mdr determination: ppf alleges bone fracture.At this time the location of the bone fracture is unknown.The acetabular cup is being reported for the alleged bone fracture at this time due to it being the most likely to fracture.If/when more information is received, the pc will be updated as needed.Occupation: initial reporter occupation: lawyer.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: patient was revised to address infection.Update: 10/26/2015 litigation received.Litigation alleges patient suffers from pain.The head and liner are now being reported.Update ad 30 aug 2018.(b)(4) has been re-opened under (b)(4) due to receipt of ppf, sticker sheets and implant records.In addition to what were previously alleged, ppf alleges metal wear, metallosis and bone fracture.Doi: (b)(6) 2010; dor: (b)(6) 2015; right hip.At this time it¿s unknown where the fracture occurred.If/when more information is received, the pc will be updated as needed.The patient has bilateral hip implants, please see (b)(4) for the left hip.

Manufacturer Narrative

Product complaint # (b)(4).

Event Description

Pfs alleges lack of mobility, chronic insomnia, mental and emotional strain, felt ill(anxiety, depressed, nausea, tired).After review of medical records, patient was revised to addressed septic right hip arthroplasty.Operative notes indicated cloudy fluid upon in fascia.There was a huge thick capsule over greater trochanter.The medial portion of the bone inadvertently did crack.Confirmed in medical records that fracture was on femur.Doi: (b)(6) 2010; dor: (b)(6) 2015; right hip.

Manufacturer Narrative

This medwatch report is being retracted since it was found that there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of the device.

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.Additional narrative: added: evaluation codes.

Manufacturer Narrative

This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: PINNACLE SECTOR II CUP 56MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9266394
• MDR Text Key: 173019412
• Report Number: 1818910-2019-113581
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295009849
• UDI-Public: 10603295009849
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2020
• Device Catalogue Number: 121722056
• Device Lot Number: EE7NN1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 118