MAUDE Adverse Event Report: ZIMMER GMBH COCR HEAD, L, 38/+4, TAPER 12/14; INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: durasulâ® constrained insert size 38mm/65mm warning: do not use the liner without the appropriate size reinforcing ring in position, 44/7.5; catalog no#: 438038065; lot#: 61229951 constraining ring 38mm ep; catalog no#: 11377004; lot#: 61044287.Therapy date: (b)(6) 2017.The manufacturer did receive surgical reports and timeline of events for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the right side and underwent revision surgery due to dislocation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Event description: a patient had an initial right tha on an unknown date with unknown products.Subsequently, the patient was revised on (b)(6) 1999 due to failed painful right tha.A revision of the acetabular components was performed on (b)(6) 2010 due to mechanical loosening and dislocation and again on (b)(6) 2017 due to displacement of the right hip prosthesis.Head, liner and constraining ring were removed and replaced.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Operative report, (b)(6) 2010: postoperative diagnosis recurrent instability, right hip arthroplasty, 10 years after revision due to recurrent instability in 1999.Procedure implant exchange; acetabular component only, with revision of right hip arthroplasty.Modifier extensive soft tissue and bony involvement of reactive soft tissue changes presumably from third body wear.Dissection required for removing large granuloma approx.The size of a large coffee cup.The frozen sections were negative for acute inflammation.The fit was excellent.The locking ring was placed once the head was reduced with a 38-mm head.Mutual neck length and stability was good.(b)(6) hospital stat discharge summary (electronically signed (b)(6) 2010): discharge diagnosis status post left hip arthroplasty revision x2 (3 prior hip surgeries with subsequent instability with multiple dislocations prior to this recent hospitalization.Now status post revision arthroplasty with polyethylene exchange and conversion to a constrained right hip arthroplasty) operations and procedures postsurgical cultures were negative for infection.He has remained leukopenic with white blood cell count around 2000-3000 presurgically, he had positive mrsa nasal swab and is on bactroban treatment.He currently has a rehab bed available and is felt appropriate for his needs given limited home situation and his weakness of his right hip abductors and propensity for dislocation without further therapy and/or use of a brace.It is recommended at this time that he be either in a knee immobilizer or his abduction hip dislocation preventing brace at all times.Pathology examination from (b)(6) 2017: negative for acute inflammation.Patient data: (b)(6) , male, born (b)(6) 1956, significant past medical history consisting of oa, failed rtha (multiple), hx of mrsa (nares).Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: a patient had an initial right tha on an unknown date with unknown products.Subsequently, the patient was revised on (b)(6) 1999 due to failed painful right tha.A revision of the acetabular components was performed on (b)(6) 2010 due to mechanical loosening and dislocation and again on (b)(6) 2017 due to displacement of the right hip prosthesis.Head, liner and constraining ring were removed and replaced.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the medical records submitted, the reported dislocation can be confirmed.Nevertheless, no radiographs of the dislocation were provided; therefore, the implant alignment and the patient's anatomy, as well as their changes over time in vivo, could not be evaluated.According to the medical records it is possible that patient factors such as weakness of right hip abductors and propensity for dislocation led or contributed to the recurrent dislocations.Nevertheless, an exact cause could not be identified.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
No change to previously reported event.

• Brand Name: COCR HEAD, L, 38/+4, TAPER 12/14
• Common Device Name: INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10394713
• Report Number: 0009613350-2020-00372
• Device Sequence Number: 16799003
• Product Code: LPH
• UDI-Device Identifier: 00889024283299
• UDI-Public: 00889024283299
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K993259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: Lay User/Patient
• Device Expiration Date: 05/15/2011
• Device Model Number: N/A
• Device Catalogue Number: 01.01012.387
• Device Lot Number: 2335654
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention