MAUDE Adverse Event Report: ZIMMER GMBH ALLOCLASSIC, SL STEM, OFFSET, UNCEMENTED, 4, TAPER 12/14; MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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 Description

Patient was implanted on unknown side and underwent revision due to pain and loosening.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of initial medwatch.New information received: - patient date of birth.Investigation of this incident is currently ongoing, a follow up report will be submitted when additional information becomes available.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to event description.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: dhr review: as no lot number was provided, the device history records could not be reviewed.Trend analysis: analysis could not be performed as no item number is available.Event description: it was reported that the product was implanted on (b)(6) 2009 and diagnosed loosening on (b)(6) 2010 and explanted on an unknown date due to pain, loosening.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.Conclusion: it was reported that the product was implanted on (b)(6) 2009 and diagnosed loosening on (b)(6) 2010 and explanted on an unknown date due to pain, loosening.The in vivo time of the device is 1 year 6 months.The dhr check could not be performed as the lot number was not available.The compatibility check could not be performed as no product information was provided.Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implant were received; therefore the condition of the component is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.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 Description

Please refer to report 0009613350-2019-00401.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional and corrected information are filled in the following fields: additional: d7 - h4.Correction: b4 - d1 - d2 - d4 - d11 - g4 - g5 - g7 - h2 - h10.D11 - medical products and therapy date detail of product: - item number 0100126658, item name durasul® alloclassic®, csf insert, 58/32, lot #2474598 - item number 173206, item name sulox, head, m, 32/0, taper 12/14, lot # 249025 - item number 00000003534, item name alloclassic csf anchorage cap 58, lot #2484894.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 Description

Please refer to report 0009613350-2019-00401.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Event summary: it was reported that the patient was implanted with a total hip prosthesis on (b)(6) 2009.Postoperatively the patient experienced a fall and since then is always experiencing pain and discomfort.Positive bone scan for aseptic loosening.The revision of stem and head took place on (b)(6) 2010.Review of received data: x-ray: 5 x-rays have been received and evaluated by an hcp from medical metrics.Assessment of imaging: on (b)(6) 2009: left total hip arthroplasty in place, radiolucent acetabular cage in place of an acetabular cup and recent postsurgical change including subcutaneous emphysema and surgical drain.No fracture seen.On (b)(6) 2009: two views demonstrate left total hip arthroplasty.Femoral component is otherwise intact.Radiolucent cage within the acetabular region.No radiolucency.Moderate to severe degenerative changes of the right hip.On (b)(6) 2009: left total hip arthroplasty.Femoral component is otherwise intact.No radiolucency.Radiolucent cage within the left acetabular cup without radiolucency.Osteopenia.Severe degenerative changes of the right hip.On (b)(6) 2010: left total hip arthroplasty.Radiolucency at the bone hardware interface of the proximal left femoral component.Radiolucent cage involving the acetabulum.New right total hip arthroplasty in place.Impressions: left total hip arthroplasty with radiolucent cage in the expected region of an acetabular cup.New radiolucency is seen at the bone hardware interface of the proximal femur which could indicate loosening on (b)(6) 2010.Overall fit and alignment of the left hip implants is appropriate.Normal bone quality.Positioning of the radiolucent cage appears to be within normal limits.No significant lucency is seen surrounding the femoral component until (b)(6) 2010 where there is newly identified radiolucency at the bone hardware interface of the proximal femur.Initial implantation report dated (b)(6) 2009: diagnosis: coxarthrosis left hip side procedure: cementless total hip procedure no complications are noted.Revision report dated (b)(6) 2010: indication: post implantation patient fell and never fully recovered.Hint of stem loosening.Stem replacement decided.Diagnosis: aseptic stem loosening procedure: revision of femoral stem.Using the extraction instrument, the stem cannot be explanted at first.Stem found to be distally well anchored.Therefore it is decided to window the bone and the stem can be removed successfully.Only a few amount of synovitic tissue detected.Implantation of the new femoral stem and head as well as cerclages.Review of product documentation: all involved devices are intended for treatment.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Conclusion summary: it was reported that the patient was implanted with a total hip prosthesis on (b)(6) 2009.Postoperatively the patient experienced a fall and since then is always experiencing pain and discomfort.Positive bone scan for aseptic loosening.The revision of stem and head took place on (b)(6) 2010.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production for the known lot numbers.The investigation results did not identify a non-conformance or a complaint out of box (coob).X-ray review revealed radiolucency at the bone hardware interface of the proximal femur which could indicate loosening on (b)(6) 2010.However, during revision surgery, the stem was found to be distally well anchored and therefore difficult to explant.Moreover, it remains unknown which impact the reported fall of the patient had on the performance of the implant.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for the reported event.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).

• Brand Name: ALLOCLASSIC, SL STEM, OFFSET, UNCEMENTED, 4, TAPER 12/14
• Type of Device: MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8747225
• MDR Text Key: 149623956
• Report Number: 0009613350-2019-00401
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K033664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.00121.040
• Device Lot Number: 2471081
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: REFER TO H10
• Patient Outcome(s): Hospitalization; Required Intervention