MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFCSIG CEM FEM STEM 5DG13X90MM; KNEE FEMORAL STEM

Model Number	96-0720
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/15/2009
Type of Reportable Event	Serious Injury
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
I have been involved in a case today of a revision of a revised tkr, sigma ps.The original surgery date was 12 years ago (date will be confirmed), on opening the patient the cavity was covered in metallosis and metal particles.On removal of the femur the adaptor and bolt seem to be loose.Doi: (b)(6) 2004, dor: (b)(6).2009,, left knee.
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.H10 additional narrative: added: b5, d6a, and d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
Event or Problem Description
From the the provided photos and returned devices, it was determined there was no adapter used with the femoral construct.Instead the construct involved the stem bolt and stem assembly where no adapter is used for this configuration.No previous revision was involved.Uncomplicated surgery using standard technique and torque limiting device to attach stem.Standard surgical time (not extended).It was the left side involved in this event.No trauma to knee at any time post surgery.Cement product was not from depuy.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the received device was forwarded to commercialized product development for evaluation.Review of the received device confirm the reported event.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: PFCSIG CEM FEM STEM 5DG13X90MM
• Common Device Name: KNEE FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11664914
• Report Number: 1818910-2021-07859
• Device Sequence Number: 2980467
• Product Code: JWH
• UDI-Device Identifier: 10603295233763
• UDI-Public: 10603295233763
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2009
• 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): 04/07/2021

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: 96-0720
• Device Catalogue Number: 960720
• Device Lot Number: C28M94
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 04/07/2021; 05/10/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 04/22/2021; 05/20/2021
• 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: P.F.C.* FLUT TIB ROD 115X10MM; PFC SIGMA STAB+ INS 17.5MM SZ2; PFC* MOD PLUS TIBIAL TRAY SZ 2; PFC*MOD PL TB WDG STP 1OMM SZ2; PFC*SIGMA C/S NPOR FEM LT SZ 2; PFC*SIGMA DIS AUG 8MM,SZ2,LEFT; PFCSIG +/-2FEMOFFSET STMBLT; PFCSIG CEM FEM STEM 5DG13X90MM; P.F.C.* FLUT TIB ROD 115X10MM; PFC SIGMA STAB+ INS 17.5MM SZ2; PFC* MOD PLUS TIBIAL TRAY SZ 2; PFC*MOD PL TB WDG STP 1OMM SZ2; PFC*SIGMA C/S NPOR FEM LT SZ 2; PFC*SIGMA DIS AUG 8MM,SZ2,LEFT; PFCSIG +/-2FEMOFFSET STMBLT; PFCSIG CEM FEM STEM 5DG13X90MM
• Outcome Attributed to Adverse Event: Required Intervention