MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-31-052
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	01/13/2021
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
The primary surgery was performed on (b)(6) 2021 and following the postoperative control x-ray the cup had tipped over.The revision was the following day, (b)(6) 2021.Did the patient experience a post-op device malfunction? -no.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing?unknown, did the patient require revision surgery or hardware removal? yes, was device explanted? true, hardware/explant removal due to: cup had tipped over , did patient require revision surgery? true, if yes, date of revision surgery.(b)(6) 2021, patient status/ outcome / consequences yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? revision, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, is the patient part of a clinical study unknown, (b)(4), device property of none, device in possession of none, ip-01061148, device property of none, device in possession of none, ip-01061149, device property of none, device in possession of none, by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Examination of the provided x-ray images confirms a highly mal-positioned acetabular cup.The images do not depict before and post movement of the cups position.It is extremely mal-positioned however and it is reasonable it was not implanted in this position.A root cause for it's movement after approximately one day implanted cannot be determined.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 : 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.
Event or Problem Description
Yes she had pain following the tilting of the cup b.No c.Left.A.Was the patient experiencing any adverse symptoms that led to the revision surgery? answer: yes she had pain following the tilting of the cup.B.Was there a surgical delay during revision surgery? if yes, what was the duration of the delay? answer: no.C.What is the affected side involved in this event? answer: left.F.Please provide patient initials if available.Answer: none.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINN 100 W/GRIPTION 52MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11214903
• Report Number: 1818910-2021-01683
• Device Sequence Number: 3805501
• Product Code: KWA
• UDI-Device Identifier: 10603295010203
• UDI-Public: 10603295010203
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2021

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: 1217-31-052
• Device Catalogue Number: 121731052
• Device Lot Number: 9488583
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 01/26/2021; 03/26/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 01/29/2021; 03/29/2021
• 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: DELTA CER HEAD 12/14 36MM +1.5; EA DELTA CER INSERT 36IDX52OD; PINN 100 W/GRIPTION 52MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR